Advisory Committee; Science Board to the Food and Drug Administration; Renewal, 33939-33940 [2018-15297]
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Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
Hampshire Ave., Bldg. 51, Rm. 3330,
Silver Spring, MD 20993, 301–796–
0151.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Innovative Approaches for
Nonprescription Drug Products.’’ FDA
approves new drugs as prescription or
nonprescription drug products under
section 505 of the Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355). A drug product must be dispensed
by prescription if it is not safe to use
except under the supervision of a
practitioner licensed by law to
administer the drug (health care
practitioner) (see section 503(b)(1) of the
FD&C Act (21 U.S.C. 353(b)(1)). If a drug
product does not meet the criteria for
prescription-only dispensing, it may be
marketed as a nonprescription drug
product. FDA determines whether the
information submitted as part of a new
drug application (NDA) for a
nonprescription drug product is
sufficient to ensure that the drug
product is safe and effective for
nonprescription use under the
conditions prescribed, recommended, or
suggested in its proposed labeling (see
section 505(d) and 503(b)(1) of the
FD&C Act.
Nonprescription drug products must
comply with applicable labeling
requirements for over-the-counter (OTC)
drug products under 21 CFR part 201,
including, but not limited to, the format
and content requirements for OTC drug
product labeling under § 201.66.
Labeling created to satisfy the
requirements in § 201.66 is commonly
referred to as the DFL. The DFL is
intended to help enable consumers to
appropriately self-select and use the
nonprescription drug product safely and
effectively.
FDA has received a number of
inquiries about: (1) Additional labeling,
beyond the DFL, that FDA can approve
for nonprescription drug products and
(2) whether applications may be
submitted for nonprescription drug
products with one or more additional
conditions that consumers must fulfill
to ensure that the drug product is safe
and effective for nonprescription use.
FDA is issuing this draft guidance to
describe two innovative approaches to
consider that may be useful for
demonstrating safety and effectiveness
for a nonprescription drug product in
cases where the DFL alone is not
sufficient to ensure that the drug
product can be used safely and
effectively in a nonprescription setting:
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(1) The development of labeling in
addition to the DFL and (2) the
implementation of additional conditions
so that consumers appropriately selfselect and use the product. The
appropriateness and specific details of
either of these approaches will depend
on the circumstances that apply to a
particular drug product. FDA believes
the innovative approaches described in
this draft guidance could lead to the
approval of a wider range of
nonprescription drug products. FDA
currently intends to issue a proposed
rule that provides more details
regarding the use of additional
conditions for nonprescription drug
products.
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 current thinking of FDA
on ‘‘Innovative Approaches for
Nonprescription Drug Products.’’ 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. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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
submission of NDAs under 21 CFR
314.50 to market nonprescription drug
products has been approved by OMB
under control number 0910–0001. In
addition, OTC Drug Facts Labeling
requirements under § 201.66 have been
approved under OMB control number
0910–0340.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15296 Filed 7–17–18; 8:45 am]
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33939
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1324]
Advisory Committee; Science Board to
the Food and Drug Administration;
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the renewal of the Science
Board to the Food and Drug
Administration (Committee) by the
Commissioner of Food and Drugs
(Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Science Board to
the Food and Drug Administration for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until June 26, 2020.
DATES: Authority for the Science Board
to the Food and Drug Administration
will expire on June 26, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the
Commissioner, Food and Drug
Administration, White Oak Building 1,
Rm. 3309, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
4769, rakesh.raghuwanshi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Science Board to the Food and Drug
Administration. The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Science Board
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility. The
Science Board shall provide advice to
the Commissioner and other appropriate
officials on specific complex scientific
and technical issues important to FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board will
provide advice that supports the Agency
in keeping pace with technical and
scientific developments, including in
SUMMARY:
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amozie on DSK3GDR082PROD with NOTICES1
33940
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
regulatory science; and input into the
Agency’s research agenda; and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency-sponsored
intramural and extramural scientific
research programs.
The Committee shall consist of a core
of 21 voting members including a Chair
and Co-Chair. The members, Chair, and
Co-Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of food science, safety, and nutrition;
chemistry; pharmacology; translational
and clinical medicine and research;
toxicology; biostatistics; medical
devices; imaging; robotics; cell and
tissue based-products; regenerative
medicine; public health and
epidemiology; international health and
regulation; product safety; product
manufacturing sciences and quality; and
other scientific areas relevant to FDA
regulated products such as systems
biology, informatics, nanotechnology,
and combination products. Members
will be invited to serve for overlapping
terms of up to 4 years. Almost all nonFederal members of this committee
serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. The Committee may
also include technically qualified
Federal members. The Commissioner or
designee shall have the authority to
select members of other scientific and
technical FDA advisory committees
(normally not to exceed 10 members) to
serve temporarily as voting members
and to designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
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requirements. If functioning as a
medical device panel, a non-voting
representative of consumer interests and
a non-voting representative of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Science
BoardtotheFoodandDrug
Administration/ucm115356.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15297 Filed 7–17–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1771]
Metal Expandable Biliary Stents—
Premarket Notification (510(k))
Submissions; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Metal Expandable
Biliary Stents—Premarket Notification
(510(k)) Submissions.’’ This draft
guidance provides recommendations for
information and testing that should be
included in 510(k) submissions for
metal expandable biliary stents and
their associated delivery systems
intended to provide luminal patency of
malignant strictures in the biliary tree.
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by September 17, 2018 to ensure that
the Agency considers your comment on
SUMMARY:
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this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1771 for ‘‘Metal Expandable
Biliary Stents—Premarket Notification
(510(k)) Submissions.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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]]>Agencies
[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33939-33940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15297]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1324]
Advisory Committee; Science Board to the Food and Drug
Administration; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the renewal of the Science Board to the Food and Drug Administration
(Committee) by the Commissioner of Food and Drugs (Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Science Board to the Food and Drug Administration for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until June 26, 2020.
DATES: Authority for the Science Board to the Food and Drug
Administration will expire on June 26, 2020, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the Commissioner, Food and Drug
Administration, White Oak Building 1, Rm. 3309, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-4769,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Science Board to the Food and Drug Administration. The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Science Board advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility. The Science Board shall provide advice to the
Commissioner and other appropriate officials on specific complex
scientific and technical issues important to FDA and its mission,
including emerging issues within the scientific community.
Additionally, the Science Board will provide advice that supports the
Agency in keeping pace with technical and scientific developments,
including in
[[Page 33940]]
regulatory science; and input into the Agency's research agenda; and on
upgrading its scientific and research facilities and training
opportunities. It will also provide, where requested, expert review of
Agency-sponsored intramural and extramural scientific research
programs.
The Committee shall consist of a core of 21 voting members
including a Chair and Co-Chair. The members, Chair, and Co-Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of food science, safety, and nutrition;
chemistry; pharmacology; translational and clinical medicine and
research; toxicology; biostatistics; medical devices; imaging;
robotics; cell and tissue based-products; regenerative medicine; public
health and epidemiology; international health and regulation; product
safety; product manufacturing sciences and quality; and other
scientific areas relevant to FDA regulated products such as systems
biology, informatics, nanotechnology, and combination products. Members
will be invited to serve for overlapping terms of up to 4 years. Almost
all non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. The Committee may also include technically qualified Federal
members. The Commissioner or designee shall have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) Expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements. If functioning as a
medical device panel, a non-voting representative of consumer interests
and a non-voting representative of industry interests will be included
in addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm115356.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15297 Filed 7-17-18; 8:45 am]
BILLING CODE 4164-01-P
