National Human Genome Research Institute; Notice of Closed Meeting, 10909 [2011-4304]
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Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices
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Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kristen E. Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–5400; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Medication Guides—Distribution
Requirements and Inclusion of
Medication Guides in Risk Evaluation
and Mitigation Strategies (REMS).’’ This
draft guidance is intended to address
two topics pertaining to Medication
Guides for drug and biological products.
Medication Guides are primarily for
prescription drug and biological
products used on an outpatient basis
without direct supervision by a
healthcare professional. Questions have
arisen concerning when a Medication
Guide must be distributed with a drug
or biological product dispensed to a
healthcare professional for
administration to a patient in certain
situations, for example, in an inpatient
setting or an outpatient setting such as
a clinic or infusion center. This draft
guidance is intended to articulate the
circumstances under which FDA
intends to exercise enforcement
discretion regarding Medication Guide
distribution.
The second topic addressed by the
draft guidance is when a Medication
Guide will be required as part of a
REMS. Under section 505–1(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355–1(e)),
FDA may require that a REMS for a drug
include one or more of the elements
described in section 505–1(e), including
(when the criteria in part 208 (21 CFR
part 208) are met), the requirement for
an applicant to develop a Medication
Guide for distribution to each patient
when the drug is dispensed. Since the
enactment of the Food and Drug
Administration Amendments Act of
2007, FDA has, as a matter of policy,
considered any new Medication Guide
(or safety-related changes to an existing
Medication Guide) to be part of a REMS.
However, the Agency has the authority
to determine, based on the risks of a
drug and public health concern, how a
Medication Guide should be required
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when the standard in part 208 is met.
Based on the risks and public health
concern, the Agency may require:
(1) A Medication Guide in accordance
with part 208 that is not a part of a
REMS or
(2) A Medication Guide in accordance
with part 208 and section 505–1 of the
FD&C Act that is part of a REMS, which
will include other parts of a REMS (such
as the timetable for submission of
assessments) and possibly other REMS
elements (including elements to assure
safe use).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on when FDA intends to exercise
enforcement discretion regarding
Medication Guide distribution and
inclusion of Medication Guides in
REMS. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 §§ 314.70 and 600.12
have been approved under OMB control
numbers 0910–0001 and 0910–0338; the
collections of information in part 208
have been approved under OMB control
number 0910–0393.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
PO 00000
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BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4341 Filed 2–25–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
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 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: Center for Inherited
Disease Research Access Committee.
Date: March 15, 2011.
Time: 11 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call.)
Contact Person: Ken D. Nakamura, PhD,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 5635
Fishers Lane, Suite 4076, MSC 9306,
Rockville, MD 20852. 301–402–0838.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS).
Dated: February 18, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–4304 Filed 2–25–11; 8:45 am]
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[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Page 10909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4304]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Human Genome Research Institute; Notice of Closed
Meeting
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
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: Center for Inherited Disease Research Access
Committee.
Date: March 15, 2011.
Time: 11 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5635 Fishers Lane,
Bethesda, MD 20892. (Telephone Conference Call.)
Contact Person: Ken D. Nakamura, PhD, Scientific Review Officer,
Scientific Review Branch, National Human Genome Research Institute,
National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC
9306, Rockville, MD 20852. 301-402-0838.
(Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human
Genome Research, National Institutes of Health, HHS).
Dated: February 18, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-4304 Filed 2-25-11; 8:45 am]
BILLING CODE 4140-01-P
