80 FR 36548 - National Library of Medicine; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 122 (June 25, 2015)

Page Range		36548-36548
FR Document		2015-15602

Federal Register, Volume 80 Issue 122 (Thursday, June 25, 2015)

[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Page 36548]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Library of Medicine; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App), notice is hereby given of a meeting of the 
Board of Scientific Counselors, National Center for Biotechnology 
Information.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    The meeting will be closed to the public as indicated below in 
accordance with the provisions set forth in section 552b(c)(6), Title 5 
U.S.C., as amended for review, discussion, and evaluation of individual 
intramural programs and projects conducted by the NATIONAL LIBRARY OF 
MEDICINE, including consideration of personnel qualifications and 
performance, and the competence of individual investigators, the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy.

    Name of Committee: Board of Scientific Counselors, National 
Center for Biotechnology Information.
    Date: December 1, 2015.
    Open: 8:30 a.m. to 12:00 p.m.
    Agenda: Program Discussion.
    Place: National Library of Medicine, Building 38, 2nd Floor, The 
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
    Closed: 12:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate personal qualifications and 
performance, and competence of individual investigators.
    Place: National Library of Medicine, Building 38, 2nd Floor, The 
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
    Open: 2:00 p.m. to 3:00 p.m.
    Agenda: Program Discussion.
    Place: National Library of Medicine, Building 38, 2nd Floor, The 
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
    Contact Person: David J. Lipman, MD, Director, National Center 
of Biotechnology Information, National Library of Medicine, 
Department of Health and Human Services, Building 38A, Room 8N805, 
Bethesda, MD 20892, 301-435-5985, [email protected].

    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.

(Catalogue of Federal Domestic Assistance Program No. 93.879, 
Medical Library Assistance, National Institutes of Health, HHS).

    Dated: June 19, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-15602 Filed 6-24-15; 8:45 am]
 BILLING CODE 4140-01-P

36548 Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices

20993–0002, 301–796–7546; or Stephen control numbers 0910–0014 and 0910– competence of individual investigators,
Ripley, Center for Biologics Evaluation 0001, respectively. the disclosure of which would
and Research, Food and Drug constitute a clearly unwarranted
III. Comments
Administration, 10903 New Hampshire invasion of personal privacy.
Ave., Bldg. 71, Rm. 7301, Silver Spring, Interested persons may submit either
Name of Committee: Board of Scientific
MD 20993–0002, 240–402–7911. electronic comments regarding this Counselors, National Center for
SUPPLEMENTARY INFORMATION:
document to http://www.regulations.gov Biotechnology Information.
or written comments to the Division of Date: December 1, 2015.
I. Background Dockets Management (see ADDRESSES). It Open: 8:30 a.m. to 12:00 p.m.
is only necessary to send one set of Agenda: Program Discussion.
FDA is announcing the availability of Place: National Library of Medicine,
a guidance for industry entitled comments. Identify comments with the
docket number found in brackets in the Building 38, 2nd Floor, The Lindberg Room,
‘‘Allowable Excess Volume and Labeled 8600 Rockville Pike, Bethesda, MD 20892.
Vial Fill Size in Injectable Drug and heading of this document. Received
Closed: 12:00 p.m. to 2:00 p.m.
Biological Products.’’ This guidance comments may be seen in the Division Agenda: To review and evaluate personal
replaces the draft guidance of the same of Dockets Management between 9 a.m. qualifications and performance, and
name that published in the Federal and 4 p.m., Monday through Friday, and competence of individual investigators.
Register of March 14, 2014 (79 FR will be posted to the docket at http:// Place: National Library of Medicine,
www.regulations.gov. Building 38, 2nd Floor, The Lindberg Room,
14517). FDA is concerned that injectable
8600 Rockville Pike, Bethesda, MD 20892.
vial misuse, including unsafe handling IV. Electronic Access Open: 2:00 p.m. to 3:00 p.m.
and injection techniques, has led to an Agenda: Program Discussion.
Persons with access to the Internet
increase in vial contamination and an Place: National Library of Medicine,
may obtain the document at http://
increased risk of bloodborne illness Building 38, 2nd Floor, The Lindberg Room,
www.fda.gov/Drugs/Guidance 8600 Rockville Pike, Bethesda, MD 20892.
transmission between patients. This
ComplianceRegulatoryInformation/ Contact Person: David J. Lipman, MD,
guidance clarifies the FDA requirements
Guidances/default.htm, http:// Director, National Center of Biotechnology
and regulations pertaining to allowable
www.fda.gov/BiologicsBloodVaccines/ Information, National Library of Medicine,
excess volume in injectable vials and
GuidanceComplianceRegulatory Department of Health and Human Services,
describes when justification is needed Building 38A, Room 8N805, Bethesda, MD
Information/default.htm, or http://
for a proposed excess volume in an 20892, 301–435–5985, dlipman@
www.regulations.gov.
injectable drug or biological product. mail.nih.gov.
This guidance also discusses the Dated: June 22, 2015.
Any interested person may file written
importance of appropriate fill volume Leslie Kux, comments with the committee by forwarding
and recommends that labeled vial fill Associate Commissioner for Policy. the statement to the Contact Person listed on
sizes be appropriate for the use and [FR Doc. 2015–15637 Filed 6–24–15; 8:45 am] this notice. The statement should include the
dosing of the drug and biological BILLING CODE 4164–01–P
name, address, telephone number and when
product. applicable, the business or professional
In the Federal Register of March 14, affiliation of the interested person.
In the interest of security, NIH has
2014 (79 FR 14517), a draft guidance DEPARTMENT OF HEALTH AND
instituted stringent procedures for entrance
was published entitled ‘‘Draft Guidance HUMAN SERVICES onto the NIH campus. All visitor vehicles,
for Industry on Allowable Excess including taxicabs, hotel, and airport shuttles
Volume and Labeled Vial Fill Size in National Institutes of Health will be inspected before being allowed on
Injectable Drug and Biological Products; campus. Visitors will be asked to show one
Availability.’’ We have carefully National Library of Medicine; Notice of form of identification (for example, a
reviewed and considered the comments Meeting government-issued photo ID, driver’s license,
that were received on the draft guidance Pursuant to section 10(a) of the or passport) and to state the purpose of their
and have made changes for clarification. visit.
Federal Advisory Committee Act, as
This guidance is being issued amended (5 U.S.C. App), notice is (Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
consistent with FDA’s good guidance hereby given of a meeting of the Board Assistance, National Institutes of Health,
practices regulation (21 CFR 10.115). of Scientific Counselors, National HHS).
The guidance represents the current Center for Biotechnology Information.
thinking of FDA on allowable excess fill The meeting will be open to the Dated: June 19, 2015.
volume and labeled vial fill size for public as indicated below, with Michelle Trout,
injectable drug and biological products attendance limited to space available. Program Analyst, Office of Federal Advisory
packaged in vials and ampules. It does Individuals who plan to attend and Committee Policy.
not establish any rights for any person need special assistance, such as sign [FR Doc. 2015–15602 Filed 6–24–15; 8:45 am]
and is not binding on FDA or the public. language interpretation or other BILLING CODE 4140–01–P
You can use an alternative approach if reasonable accommodations, should
it satisfies the requirements of the notify the Contact Person listed below
applicable statutes and regulations. in advance of the meeting. DEPARTMENT OF HEALTH AND
The meeting will be closed to the HUMAN SERVICES
II. Paperwork Reduction Act of 1995 public as indicated below in accordance
asabaliauskas on DSK5VPTVN1PROD with NOTICES

This guidance refers to previously with the provisions set forth in section National Institutes of Health
approved collections of information that 552b(c)(6), Title 5 U.S.C., as amended
National Institute of Mental Health;
are subject to review by the Office of for review, discussion, and evaluation of
Notice of Closed Meetings
Management and Budget (OMB) under individual intramural programs and
the Paperwork Reduction Act of 1995 projects conducted by the NATIONAL Pursuant to section 10(d) of the
(44 U.S.C. 3501–3520). The collections LIBRARY OF MEDICINE, including Federal Advisory Committee Act, as
of information in 21 CFR parts 312 and consideration of personnel amended (5 U.S.C. App.), notice is
314 have been approved under OMB qualifications and performance, and the hereby given of the following meetings.

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Document Created: 2015-12-15 14:16:42
Document Modified: 2015-12-15 14:16:42

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		December 1, 2015.
FR Citation		80 FR 36548

80 FR 36548 - National Library of Medicine; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 122 (June 25, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health