83 FR 17421 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 76 (April 19, 2018)

Page Range		17421-17421
FR Document		2018-08171

Federal Register, Volume 83 Issue 76 (Thursday, April 19, 2018)

[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Page 17421]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08171]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, 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 Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Clinical Trial Implementation 
Grant (R01).
    Date: May 11, 2018.
    Time: 11:00 a.m. to 12:30 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: J. Bruce Sundstrom, Ph.D., Scientific Review 
Officer Scientific Review Program, Division of Extramural 
Activities, Room 3G11A, National Institutes of Health/NIAID, 5601 
Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, 240-669-5045, 
sundstromj@niaid.nih.gov.

(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: April 13, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-08171 Filed 4-18-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices 17421

Evaluation and Research, (HFD–860), have been approved under OMB control Time: 11:00 a.m. to 12:30 p.m.
Food and Drug Administration, 10903 number 0910–0001. The submission of Agenda: To review and evaluate grant
New Hampshire Ave., Bldg. 51, Rm. prescription drug product labeling applications.
Place: National Institutes of Health, 5601
4132, Silver Spring, MD 20993, 301– under 21 CFR 201.56 and 201.57 is
Fishers Lane, Rockville, MD 20892
796–1697. approved under OMB control number (Telephone Conference Call).
SUPPLEMENTARY INFORMATION: 0910–0572. Contact Person: J. Bruce Sundstrom, Ph.D.,
The guidance also discusses labeling Scientific Review Officer Scientific Review
I. Background for MDI and DPI drug products, and Program, Division of Extramural Activities,
FDA is announcing the availability of references 21 CFR part 201. In the Room 3G11A, National Institutes of Health/
a draft guidance for industry entitled Federal Register of December 18, 2014 NIAID, 5601 Fishers Lane, MSC 9823,
‘‘Metered Dose Inhaler (MDI) and Dry (79 FR 75506), FDA published its Bethesda, MD 20892–9823, 240–669–5045,
Powder Inhaler (DPI) Drug Products— proposed rule on the electronic sundstromj@niaid.nih.gov.
Quality Considerations.’’ This guidance distribution of prescribing information (Catalogue of Federal Domestic Assistance
describes points to consider to help for human prescription drugs, including Program Nos. 93.855, Allergy, Immunology,
ensure product quality and performance and Transplantation Research; 93.856,
biological products. In Section VII, Microbiology and Infectious Diseases
for MDIs and DPIs. It describes ‘‘Paperwork Reduction Act of 1995,’’ Research, National Institutes of Health, HHS)
chemistry, manufacturing, and controls FDA estimated the burden to design,
information recommended for inclusion test, and produce the label for a drug Dated: April 13, 2018.
in new drug applications (NDAs) and product’s immediate container and Natasha M. Copeland,
abbreviated new drug applications outer container or package, as set forth Program Analyst, Office of Federal Advisory
(ANDAs); however, the principles are in 21 CFR part 201, including §§ 201.10, Committee Policy.
applicable to products used during 201.100(b), and other sections in [FR Doc. 2018–08171 Filed 4–18–18; 8:45 am]
clinical trials and over the product subpart A and subpart B. BILLING CODE 4140–01–P
lifecycle, as well. It also provides
recommendations on certain aspects of III. Electronic Access
labeling for NDA and ANDA MDI and Persons with access to the internet DEPARTMENT OF HEALTH AND
DPI products. FDA previously may obtain the document at either HUMAN SERVICES
published a draft guidance on this topic https://www.fda.gov/Drugs/Guidance
on November 13, 1998. The present ComplianceRegulatoryInformation/ National Institutes of Health
guidance is a revision of the previous Guidances/default.htm or https://
draft, updated to reflect current Center for Scientific Review; Notice of
www.regulations.gov.
standards and requirements to enhance Closed Meeting
Dated: April 13, 2018.
understanding of development Pursuant to section 10(d) of the
Leslie Kux,
approaches for these products Federal Advisory Committee Act, as
consistent with the quality by design Associate Commissioner for Policy.
amended, notice is hereby given of the
paradigm. [FR Doc. 2018–08200 Filed 4–18–18; 8:45 am]
following meeting.
This draft guidance is being issued BILLING CODE 4164–01–P The meeting will be closed to the
consistent with FDA’s good guidance public in accordance with the
practices regulation (21 CFR 10.115). provisions set forth in sections
The draft guidance, when finalized, will DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
represent the current thinking of FDA HUMAN SERVICES as amended. The grant applications and
on ‘‘Metered Dose Inhaler (MDI) and the discussions could disclose
Dry Powder Inhaler (DPI) Drug National Institutes of Health
confidential trade secrets or commercial
Products—Quality Considerations.’’ It National Institute of Allergy and property such as patentable material,
does not establish any rights for any Infectious Diseases; Notice of Closed and personal information concerning
person and is not binding on FDA or the Meeting individuals associated with the grant
public. You can use an alternative applications, the disclosure of which
approach if it satisfies the requirements Pursuant to section 10(d) of the would constitute a clearly unwarranted
of the applicable statutes and Federal Advisory Committee Act, as invasion of personal privacy.
regulations. This guidance is not subject amended, notice is hereby given of the
to Executive Order 12866. following meeting. Name of Committee: Center for Scientific
The meeting will be closed to the Review Special Emphasis Panel; Global
II. Paperwork Reduction Act of 1995 Noncommunicable Diseases and Injury
public in accordance with the Across the Lifespan: Exploratory Research.
This guidance includes information provisions set forth in sections Date: April 25, 2018.
collection provisions that are subject to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 11:00 a.m. to 1:30 p.m.
review by the Office of Management and as amended. The grant applications and Agenda: To review and evaluate grant
Budget (OMB) under the Paperwork the discussions could disclose applications.
Reduction Act of 1995 (44 U.S.C. 3501– confidential trade secrets or commercial Place: National Institutes of Health, 6701
3520). The collections of information property such as patentable material, Rockledge Drive, Bethesda, MD 20892
referenced in this guidance that are and personal information concerning (Telephone Conference Call).
related to the burden for the submission individuals associated with the grant Contact Person: Fungai Chanetsa, MPH,
of investigational new drug applications Ph.D., Scientific Review Officer, Center for
applications, the disclosure of which
daltland on DSKBBV9HB2PROD with NOTICES

Scientific Review, National Institutes of
are covered under 21 CFR part 312 and would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 3135,
have been approved under OMB control invasion of personal privacy. MSC 7770 Bethesda, MD 20892, 301–408–
number 0910–0014. The collections of Name of Committee: National Institute of 9436, fungai.chanetsa@nih.hhs.gov.
information referenced in this guidance Allergy and Infectious Diseases Special This notice is being published less than 15
that are related to the burden for the Emphasis Panel; NIAID Clinical Trial days prior to the meeting due to the timing
submission of new drug applications Implementation Grant (R01). limitations imposed by the review and
that are covered under 21 CFR part 314 Date: May 11, 2018. funding cycle.

VerDate Sep<11>2014 17:49 Apr 18, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1

Document Created: 2018-04-19 00:41:18
Document Modified: 2018-04-19 00:41:18

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		May 11, 2018.
FR Citation		83 FR 17421

83 FR 17421 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 76 (April 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health