80 FR 60920 - National Heart, Lung, and Blood Institute Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range		60920-60921
FR Document		2015-25582

Federal Register, Volume 80 Issue 195 (Thursday, October 8, 2015)

[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60920-60921]
From the Federal Register Online  [www.thefederalregister.org]
[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

60920 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices

an appropriate cover form. Form FDA whether informal dispute resolution In the Federal Register of June 2, 2015
1571 must accompany submissions was sought prior to the formal appeal, (80 FR 31386), FDA published a 60-day
under INDs and Form FDA 356h must whether advisory committee review is notice requesting public comment on
accompany submissions under NDAs, sought, and the expected outcome; (2) a the proposed collection of information.
ANDAs, and BLAs. Both forms have statement identifying the review No comments were received.
valid OMB control numbers as follows: division/office that issued the original Burden Estimate: Provided in this
FDA Form 1571—OMB control number decision on the matter and, if document is an estimate of the annual
0910–0014, and FDA Form 356h—OMB applicable, the last Agency official that reporting burden for requests for dispute
control number 0910–0338. attempted to formally resolve the resolution. Based on data collected from
In the guidance document, CDER and matter; (3) a list of documents in the review divisions and offices within
CBER ask that a request for formal administrative file, or additional copies CDER and CBER, FDA estimates that
dispute resolution be submitted as an of such documents, that are deemed approximately eight sponsors and
amendment to the application for the necessary for resolution of the issue(s); applicants (respondents) submit
underlying product and that it be and (4) a statement that the previous requests for formal dispute resolution to
submitted to the Agency in triplicate supervisory level has already had the CDER annually and approximately one
with the appropriate form attached, opportunity to review all of the material respondent submits requests for formal
either Form FDA 1571 or Form FDA relied on for dispute resolution. The dispute resolution to CBER annually.
356h. The Agency recommends that a information that the Agency suggests The total annual responses are the total
request be submitted as an amendment submitting with a formal request for number of requests submitted to CDER
in this manner for two reasons: To dispute resolution consists of: (1) and CBER in 1 year, including requests
ensure that each request is kept in the Statements describing the issue from the for dispute resolution that a single
administrative file with the entire perspective of the person with a respondent submits more than one time.
underlying application and to ensure dispute, (2) brief statements describing FDA estimates that CDER receives
that pertinent information about the the history of the matter, and (3) the approximately 31 requests annually and
request is entered into the appropriate documents previously submitted to FDA CBER receives approximately 1 request
tracking databases. Use of the under an OMB approved collection of annually. The hours per response is the
information in the Agency’s tracking information. estimated number of hours that a
databases enables the appropriate Based on FDA’s experience with respondent would spend preparing the
Agency official to monitor progress on dispute resolution, the Agency expects information to be submitted with a
the resolution of the dispute and to that most persons seeking formal request for formal dispute resolution in
ensure that appropriate steps will be dispute resolution will have gathered accordance with this guidance,
taken in a timely manner. the materials listed previously when including the time it takes to gather and
CDER and CBER have determined and identifying the existence of a dispute copy brief statements describing the
the guidance recommends that the with the Agency. Consequently, FDA issue from the perspective of the person
following information should be anticipates that the collection of with the dispute, brief statements
submitted to the appropriate center with information attributed solely to the describing the history of the matter, and
each request for dispute resolution so guidance will be minimal. supporting information that has already
that the Center may quickly and Description of Respondents: A been submitted to the Agency. Based on
efficiently respond to the request: (1) A sponsor, applicant, or manufacturer of a experience, FDA estimates that
brief but comprehensive statement of drug or biological product regulated by approximately 8 hours on average
each issue to be resolved, including a the Agency under the Federal Food, would be needed per response.
description of the issue, the nature of Drug, and Cosmetic Act or section 351 Therefore, FDA estimates that 8 hours
the issue (i.e., scientific, procedural, or of the Public Health Service Act who will be spent per year by respondents
both), possible solutions based on requests formal resolution of a scientific requesting formal dispute resolution
information in the administrative file, or procedural dispute. under the guidance.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Requests for formal dispute resolution responses per burden per Total hours
respondents responses
respondent response

CDER ............................................................... 8 2 31 8 248
CBER ............................................................... 1 1 1 8 8

Total .......................................................... ............................ ............................ ............................ ............................ 256
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 2, 2015. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
Leslie Kux, HUMAN SERVICES hereby given of the following meetings.
mstockstill on DSK4VPTVN1PROD with NOTICES

Associate Commissioner for Policy. The meetings will be closed to the
[FR Doc. 2015–25623 Filed 10–7–15; 8:45 am] National Institutes of Health public in accordance with the
BILLING CODE 4164–01–P provisions set forth in sections
National Heart, Lung, and Blood 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Institute Notice of Closed Meetings as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the
confidential trade secrets or commercial
Federal Advisory Committee Act, as property such as patentable material,

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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60921

and personal information concerning DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
individuals associated with the grant HUMAN SERVICES HUMAN SERVICES
applications, the disclosure of which
would constitute a clearly unwarranted National Institutes of Health National Institutes of Health
invasion of personal privacy.
National Institute of Environmental Center for Scientific Review Notice of
Name of Committee: National Heart, Lung, Closed Meetings
Health Sciences; Notice of Closed
and Blood Institute Special Emphasis Panel;
Meeting Pursuant to section 10(d) of the
Lung Imaging Phase 2.
Date: November 2, 2015. Federal Advisory Committee Act, as
Pursuant to section 10(d) of the amended (5 U.S.C. App.), notice is
Time: 9:00 a.m. to 5:00 p.m.
Federal Advisory Committee Act, as hereby given of the following meetings.
Agenda: To review and evaluate grant
applications.
amended (5 U.S.C. App.), notice is The meetings will be closed to the
Place: The River Inn, 924 25th Street NW., hereby given of the following meeting. public in accordance with the
Washington, DC 20037. The meeting will be closed to the provisions set forth in sections
Contact Person: Stephanie L. Constant, public in accordance with the 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Ph.D., Scientific Review Officer, Office of provisions set forth in sections as amended. The grant applications and
Scientific Review/DERA National Heart, 552b(c)(4) and 552b(c)(6), title 5 U.S.C., the discussions could disclose
Lung, and Blood Institute, 6701 Rockledge as amended. The grant applications and confidential trade secrets or commercial
Drive, Room 7189, Bethesda, MD 20892, 301– the discussions could disclose property such as patentable material,
443–8784, constantsl@nhlbi.nih.gov confidential trade secrets or commercial and personal information concerning
Name of Committee: National Heart, Lung, property such as patentable material, individuals associated with the grant
and Blood Institute Special Emphasis Panel; applications, the disclosure of which
and personal information concerning
SBIR Phase IIB Small Market Awards. would constitute a clearly unwarranted
individuals associated with the grant
Date: November 4, 2015. invasion of personal privacy.
applications, the disclosure of which
Time: 8:30 a.m. to 10:00 a.m. Name of Committee: Center for Scientific
would constitute a clearly unwarranted
Agenda: To review and evaluate grant Review Special Emphasis Panel; Member
invasion of personal privacy.
applications. Conflict: Therapeutic Strategies for
Place: Hilton Crystal City, 2399 Jefferson Name of Committee: National Institute of Lysosomal Storage and Amino; Acid
Davis Hwy., Arlington, VA 22202. Environmental Health Sciences Special Metabolism Disorders.
Contact Person: Tony L. Creazzo, Ph.D., Emphasis Panel; Training for Career Date: November 3, 2015.
Scientific Review Officer, Office of Scientific Independence in Environmental Health Time: 11:00 a.m. to 1:00 p.m.
Sciences. Agenda: To review and evaluate grant
Review/DERA, National Heart, Lung, and
Date: November 2, 2015. applications.
Blood Institute, 6701 Rockledge Drive, Room Place: National Institutes of Health, 6701
7180, Bethesda, MD 20892–7924, 301–435– Time: 11:00 a.m. to 4:00 p.m.
Rockledge Drive, Bethesda, MD 20892,
0725, creazzotl@mail.nih.gov Agenda: To review and evaluate grant (Telephone Conference Call).
Name of Committee: National Heart, Lung, applications. Contact Person: Alessandra C Rovescalli,
and Blood Institute Special Emphasis Panel; Place: National Institute of Environmental Ph.D., Scientific Review Officer, National
NHLBI SBIR Phase IIB Bridge Awards (R44). Health Sciences, Keystone Building, Room Institutes of Health, Center for Scientific
Date: November 4, 2015. 1003A, 530 Davis Drive, Research Triangle Review, 6701 Rockledge Drive, Rm 5205
Time: 10:00 a.m. to 5:00 p.m. Park, NC 27709 (Telephone Conference Call). MSC7846, Bethesda, MD 20892, (301) 435–
Contact Person: Linda K. Bass, Ph.D., 1021, rovescaa@mail.nih.gov.
Agenda: To review and evaluate grant
applications. Scientific Review Officer, Scientific Review Name of Committee: Center for Scientific
Branch, Division of Extramural Research and Review Special Emphasis Panel; Laboratory
Place: Hilton Crystal City, 2399 Jefferson
Training, Nat’l Institute Environmental for Fluorescence Dynamics.
Davis Hwy., Arlington, VA 22202.
Health Sciences, P.O. Box 12233, MD EC–30, Date: November 8–10, 2015.
Contact Person: Susan Wohler Sunnarborg, Time: 9:00 a.m. to 11:00 a.m.
Ph.D., Scientific Review Officer, Office of Research Triangle Park, NC 27709, (919) 541–
Agenda: To review and evaluate grant
Scientific Review/DERA, National, Heart, 1307.
applications.
Lung, and Blood Institute, 6701 Rockledge (Catalogue of Federal Domestic Assistance Place: Atrium Hotel, 18700 MacArthur
Drive, Room 7182, Bethesda, MD 20892, Program Nos. 93.115, Biometry and Risk Blvd., Irvine, CA 92612.
sunnarborgsw@nhlbi.nih.gov. Estimation—Health Risks from Contact Person: Mike Radtke, Ph.D.,
(Catalogue of Federal Domestic Assistance Environmental Exposures; 93.142, NIEHS Scientific Review Officer, Center for
Hazardous Waste Worker Health and Safety Scientific Review, National Institutes of
Program Nos. 93.233, National Center for
Training; 93.143, NIEHS Superfund Health, 6701 Rockledge Drive, Room 4176,
Sleep Disorders Research; 93.837, Heart and MSC 7806, Bethesda, MD 20892, 301–435–
Vascular Diseases Research; 93.838, Lung Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower 1728, radtkem@csr.nih.gov.
Diseases Research; 93.839, Blood Diseases
Development in the Environmental Health Name of Committee: Center for Scientific
and Resources Research, National Institutes Review Special Emphasis Panel; Small
of Health, HHS) Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114, Business: Informatics.
Dated: October 2, 2015. Date: November 9, 2015.
Applied Toxicological Research and Testing,
Time: 9:00 a.m. to 5:00 p.m.
Michelle Trout, National Institutes of Health, HHS) Agenda: To review and evaluate grant
Program Analyst, Office of Federal Advisory applications.
mstockstill on DSK4VPTVN1PROD with NOTICES

Dated: October 2, 2015.
Committee Policy. Place: National Institutes of Health, 6701
Carolyn Baum,
[FR Doc. 2015–25582 Filed 10–7–15; 8:45 am] Rockledge Drive, Bethesda, MD 20892.
Program Analyst, Office of Federal Advisory Contact Person: Claire E Gutkin, Ph.D.,
BILLING CODE 4140–01–P
Committee Policy. Scientific Review Officer, Center for
[FR Doc. 2015–25583 Filed 10–7–15; 8:45 am] Scientific Review, National Institutes of
BILLING CODE 4140–01–P
Health, 6701 Rockledge Drive, Room 3106,
MSC 7808, Bethesda, MD 20892, 301–594–
3139, gutkincl@csr.nih.gov.

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Document Created: 2015-12-15 08:42:43
Document Modified: 2015-12-15 08:42:43

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		November 2, 2015.
FR Citation		80 FR 60920

80 FR 60920 - National Heart, Lung, and Blood Institute Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 195 (October 8, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health