National Library of Medicine; Notice of Meeting, 36548 [2015-15602]
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36548
Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
20993–0002, 301–796–7546; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
asabaliauskas on DSK5VPTVN1PROD with NOTICES
FDA is announcing the availability of
a guidance for industry entitled
‘‘Allowable Excess Volume and Labeled
Vial Fill Size in Injectable Drug and
Biological Products.’’ This guidance
replaces the draft guidance of the same
name that published in the Federal
Register of March 14, 2014 (79 FR
14517). FDA is concerned that injectable
vial misuse, including unsafe handling
and injection techniques, has led to an
increase in vial contamination and an
increased risk of bloodborne illness
transmission between patients. This
guidance clarifies the FDA requirements
and regulations pertaining to allowable
excess volume in injectable vials and
describes when justification is needed
for a proposed excess volume in an
injectable drug or biological product.
This guidance also discusses the
importance of appropriate fill volume
and recommends that labeled vial fill
sizes be appropriate for the use and
dosing of the drug and biological
product.
In the Federal Register of March 14,
2014 (79 FR 14517), a draft guidance
was published entitled ‘‘Draft Guidance
for Industry on Allowable Excess
Volume and Labeled Vial Fill Size in
Injectable Drug and Biological Products;
Availability.’’ We have carefully
reviewed and considered the comments
that were received on the draft guidance
and have made changes for clarification.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on allowable excess fill
volume and labeled vial fill size for
injectable drug and biological products
packaged in vials and ampules. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
VerDate Sep<11>2014
16:37 Jun 24, 2015
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control numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15637 Filed 6–24–15; 8:45 am]
BILLING CODE 4164–01–P
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
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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, dlipman@
mail.nih.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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.
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[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Page 36548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, dlipman@mail.nih.gov.
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
