83 FR 28243 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 117 (June 18, 2018)

Page Range		28243-28243
FR Document		2018-12921

Federal Register, Volume 83 Issue 117 (Monday, June 18, 2018)

[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Page 28243]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12921]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; 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: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; Immunity in the Elderly (R01).
    Date: July 9-10, 2018.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, LD30, 5601 Fishers Lane, 
Rockville, MD 20892.
    Contact Person: Julio Aliberti, Ph.D., Scientific Review 
Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 5601 Fishers 
Lane, MSC-9823, Rockville, MD 20852, 301-761-7322, 
[email protected].

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; Maintaining Immunity after 
Immunization (U01).
    Date: July 11-12, 2018.
    Time: 8:30 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5601 Fishers Lane, 
Rockville, MD 20892.
    Contact Person: Geetanjali Bansal, Ph.D., Scientific Review 
Officer, Scientific Review Program, Division of Extramural 
Activities, Room 3G49, National Institutes of Health/NIAID, 5601 
Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5073, 
[email protected].

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Investigator Initiated 
Program Project (P01).
    Date: July 11, 2018.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5601 Fishers Lane, 
Rockville, MD 20892 (Telephone Conference Call).
    Contact Person: Raymond R. Schleef, Ph.D., Senior Scientific 
Review Officer, Scientific Review Program, Division of Extramural 
Activities, Room 3E61, National Institutes of Health/NIAID, 5601 
Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, (240) 669-5019, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: June 12, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-12921 Filed 6-15-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28243

ICH Assembly is responsible for the requirements of the applicable statutes Place: National Institutes of Health, 5601
endorsement of draft guidelines and and regulations. This guidance is not Fishers Lane, Rockville, MD 20892.
adoption of final guidelines. FDA subject to Executive Order 12866. Contact Person: Geetanjali Bansal, Ph.D.,
Scientific Review Officer, Scientific Review
publishes ICH guidelines as FDA
II. Electronic Access Program, Division of Extramural Activities,
guidances. Room 3G49, National Institutes of Health/
ICH S9 (2010) was a significant Persons with access to the internet NIAID, 5601 Fishers Lane, MSC 9834,
advance in harmonizing anticancer drug may obtain the document at https:// Bethesda, MD 20892–9834, (240) 669–5073,
development. Implementation of ICH S9 www.regulations.gov, https:// geetanjali.bansal@nih.gov.
(2010) has revealed areas that are open www.fda.gov/Drugs/Guidance Name of Committee: National Institute of
to broad and divergent interpretation by ComplianceRegulatoryInformation/ Allergy and Infectious Diseases Special
both regulatory authorities and industry. Guidances/default.htm, or https:// Emphasis Panel; NIAID Investigator Initiated
For this reason, an Implementation www.fda.gov/BiologicsBloodVaccines/ Program Project (P01).
Working Group (IWG) was formed in GuidanceComplianceRegulatory Date: July 11, 2018.
October 2014 to provide additional Information/Guidances/default.htm. Time: 1:00 p.m. to 5:00 p.m.
clarity about anticancer pharmaceutical Agenda: To review and evaluate grant
Dated: June 12, 2018. applications.
development. The questions and Leslie Kux, Place: National Institutes of Health, 5601
answers developed by the IWG are Fishers Lane, Rockville, MD 20892
Associate Commissioner for Policy.
intended to facilitate the (Telephone Conference Call).
[FR Doc. 2018–12975 Filed 6–15–18; 8:45 am]
implementation of ICH S9 (2010), as Contact Person: Raymond R. Schleef,
BILLING CODE 4164–01–P
well as to continue progress in the 3Rs Ph.D., Senior Scientific Review Officer,
of Reduction, Refinement, and Scientific Review Program, Division of
Replacement in the use of animals. Extramural Activities, Room 3E61, National
In the Federal Register of September DEPARTMENT OF HEALTH AND Institutes of Health/NIAID, 5601 Fishers
19, 2016 (81 FR 64178), FDA published HUMAN SERVICES Lane, MSC 9823, Bethesda, MD 20892–9823,
a notice announcing the availability of (240) 669–5019, schleefrr@niaid.nih.gov.
National Institutes of Health (Catalogue of Federal Domestic Assistance
a draft guidance entitled ‘‘S9
Nonclinical Evaluation for Anticancer Program Nos. 93.855, Allergy, Immunology,
National Institute of Allergy and and Transplantation Research; 93.856,
Pharmaceuticals—Questions and Infectious Diseases; Notice of Closed Microbiology and Infectious Diseases
Answers.’’ The notice gave interested Meetings Research, National Institutes of Health, HHS)
persons an opportunity to submit
comments by November 18, 2016. Pursuant to section 10(d) of the Dated: June 12, 2018.
After consideration of the comments Federal Advisory Committee Act, as Natasha M. Copeland,
received and revisions to the guideline, amended, notice is hereby given of the Program Analyst, Office of Federal Advisory
a final draft of the guideline was following meetings. Committee Policy.
submitted to the ICH Assembly and The meetings will be closed to the [FR Doc. 2018–12921 Filed 6–15–18; 8:45 am]
endorsed by the regulatory agencies in public in accordance with the BILLING CODE 4140–01–P
June 2016. provisions set forth in sections
The guidance provides 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
recommendations on development of as amended. The grant applications and DEPARTMENT OF HEALTH AND
anticancer pharmaceuticals, including the discussions could disclose HUMAN SERVICES
small molecule and biotechnology- confidential trade secrets or commercial
derived products. The questions and property such as patentable material, National Institutes of Health
answers are intended to provide clarity and personal information concerning
and to facilitate a harmonized approach individuals associated with the grant Center for Scientific Review; Notice of
to the implementation of ICH S9 (2010). applications, the disclosure of which Closed Meetings
Since the publication of the draft would constitute a clearly unwarranted Pursuant to section 10(d) of the
questions and answers and receipt of invasion of personal privacy. Federal Advisory Committee Act, as
public comments, some questions were Name of Committee: National Institute of amended, notice is hereby given of the
combined for brevity and clarity or were Allergy and Infectious Diseases Special following meetings.
deleted as redundant or due to lack of Emphasis Panel; Immunity in the Elderly The meetings will be closed to the
harmonization. Several areas of (R01). public in accordance with the
particular importance include Date: July 9–10, 2018.
provisions set forth in sections
additional clarity around the scope of Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the guidance, additional as amended. The grant applications and
applications.
recommendations regarding Place: National Institutes of Health, LD30, the discussions could disclose
development of antibody-drug 5601 Fishers Lane, Rockville, MD 20892. confidential trade secrets or commercial
conjugates, and the need for recovery Contact Person: Julio Aliberti, Ph.D., property such as patentable material,
animals in general toxicology studies. Scientific Review Officer, Scientific Review and personal information concerning
This guidance is being issued Program, DEA/NIAID/NIH/DHHS, 5601 individuals associated with the grant
consistent with FDA’s good guidance Fishers Lane, MSC–9823, Rockville, MD
applications, the disclosure of which
practices regulation (21 CFR 10.115). 20852, 301–761–7322, alibertijc@
niaid.nih.gov. would constitute a clearly unwarranted
The guidance represents the current invasion of personal privacy.
amozie on DSK3GDR082PROD with NOTICES1

thinking of FDA on ‘‘S9 Nonclinical Name of Committee: National Institute of
Evaluation for Anticancer Allergy and Infectious Diseases Special Name of Committee: Center for Scientific
Emphasis Panel; Maintaining Immunity after Review Special Emphasis Panel; PAR:
Pharmaceuticals—Questions and Immunization (U01). Selected Topics in Transfusion Medicine.
Answers.’’ It does not establish any Date: July 11–12, 2018. Date: June 28–29, 2018.
rights for any person and is not binding Time: 8:30 a.m. to 2:00 p.m. Time: 10:00 a.m. to 6:00 p.m.
on FDA or the public. You can use an Agenda: To review and evaluate grant Agenda: To review and evaluate grant
alternative approach if it satisfies the applications. applications.

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Document Created: 2018-06-18 15:50:06
Document Modified: 2018-06-18 15:50:06

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 9-10, 2018.
FR Citation		83 FR 28243

83 FR 28243 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 117 (June 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health