83 FR 33939 - Advisory Committee; Science Board to the Food and Drug Administration; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 138 (July 18, 2018)

Page Range		33939-33940
FR Document		2018-15297

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.

Federal Register, Volume 83 Issue 138 (Wednesday, July 18, 2018)

[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33939-33940]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15297]


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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.

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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

Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33939

Hampshire Ave., Bldg. 51, Rm. 3330, (1) The development of labeling in DEPARTMENT OF HEALTH AND
Silver Spring, MD 20993, 301–796– addition to the DFL and (2) the HUMAN SERVICES
0151. implementation of additional conditions
so that consumers appropriately self- Food and Drug Administration
SUPPLEMENTARY INFORMATION:
select and use the product. The [Docket No. FDA–2018–N–1324]
I. Background appropriateness and specific details of
FDA is announcing the availability of either of these approaches will depend Advisory Committee; Science Board to
a draft guidance for industry entitled on the circumstances that apply to a the Food and Drug Administration;
‘‘Innovative Approaches for particular drug product. FDA believes Renewal
Nonprescription Drug Products.’’ FDA the innovative approaches described in AGENCY: Food and Drug Administration,
approves new drugs as prescription or this draft guidance could lead to the HHS.
nonprescription drug products under approval of a wider range of
section 505 of the Food, Drug, and ACTION:Notice; renewal of advisory
nonprescription drug products. FDA committee.
Cosmetic Act (FD&C Act) (21 U.S.C. currently intends to issue a proposed
355). A drug product must be dispensed rule that provides more details SUMMARY: The Food and Drug
by prescription if it is not safe to use regarding the use of additional Administration (FDA or Agency) is
except under the supervision of a conditions for nonprescription drug announcing the renewal of the Science
practitioner licensed by law to products. Board to the Food and Drug
administer the drug (health care Administration (Committee) by the
practitioner) (see section 503(b)(1) of the This draft guidance is being issued
consistent with FDA’s good guidance Commissioner of Food and Drugs
FD&C Act (21 U.S.C. 353(b)(1)). If a drug (Commissioner). The Commissioner has
product does not meet the criteria for practices regulation (21 CFR 10.115).
determined that it is in the public
prescription-only dispensing, it may be The draft guidance, when finalized, will
interest to renew the Science Board to
marketed as a nonprescription drug represent the current thinking of FDA
the Food and Drug Administration for
product. FDA determines whether the on ‘‘Innovative Approaches for an additional 2 years beyond the charter
information submitted as part of a new Nonprescription Drug Products.’’ It does expiration date. The new charter will be
drug application (NDA) for a not establish any rights for any person in effect until June 26, 2020.
nonprescription drug product is and is not binding on FDA or the public.
DATES: Authority for the Science Board
sufficient to ensure that the drug You can use an alternative approach if
product is safe and effective for to the Food and Drug Administration
it satisfies the requirements of the will expire on June 26, 2020, unless the
nonprescription use under the applicable statutes and regulations. This
conditions prescribed, recommended, or Commissioner formally determines that
guidance is not subject to Executive renewal is in the public interest.
suggested in its proposed labeling (see Order 12866.
section 505(d) and 503(b)(1) of the FOR FURTHER INFORMATION CONTACT:
FD&C Act. II. Paperwork Reduction Act of 1995 Rakesh Raghuwanshi, Office of the
Nonprescription drug products must Chief Scientist, Office of the
comply with applicable labeling This draft guidance refers to Commissioner, Food and Drug
requirements for over-the-counter (OTC) previously approved collections of Administration, White Oak Building 1,
drug products under 21 CFR part 201, information that are subject to review by Rm. 3309, 10903 New Hampshire Ave.,
including, but not limited to, the format the Office of Management and Budget Silver Spring, MD 20993, 301–796–
and content requirements for OTC drug (OMB) under the Paperwork Reduction 4769, rakesh.raghuwanshi@fda.hhs.gov.
product labeling under § 201.66. Act of 1995 (44 U.S.C. 3501–3520). The SUPPLEMENTARY INFORMATION: Pursuant
Labeling created to satisfy the submission of NDAs under 21 CFR to 41 CFR 102–3.65 and approval by the
requirements in § 201.66 is commonly 314.50 to market nonprescription drug Department of Health and Human
referred to as the DFL. The DFL is products has been approved by OMB Services pursuant to 45 CFR part 11 and
intended to help enable consumers to under control number 0910–0001. In by the General Services Administration,
appropriately self-select and use the addition, OTC Drug Facts Labeling FDA is announcing the renewal of the
nonprescription drug product safely and requirements under § 201.66 have been Science Board to the Food and Drug
effectively. approved under OMB control number Administration. The Committee is a
FDA has received a number of 0910–0340. discretionary Federal advisory
inquiries about: (1) Additional labeling, committee established to provide advice
beyond the DFL, that FDA can approve III. Electronic Access to the Commissioner. The Science Board
for nonprescription drug products and advises the Commissioner or designee
Persons with access to the internet
(2) whether applications may be in discharging responsibilities as they
may obtain the draft guidance at either
submitted for nonprescription drug relate to helping to ensure safe and
https://www.fda.gov/Drugs/Guidance
products with one or more additional effective drugs for human use and, as
conditions that consumers must fulfill ComplianceRegulatoryInformation/ required, any other product for which
to ensure that the drug product is safe Guidances/default.htm or https:// FDA has regulatory responsibility. The
and effective for nonprescription use. www.regulations.gov. Science Board shall provide advice to
FDA is issuing this draft guidance to Dated: July 12, 2018. the Commissioner and other appropriate
describe two innovative approaches to Leslie Kux, officials on specific complex scientific
amozie on DSK3GDR082PROD with NOTICES1

consider that may be useful for Associate Commissioner for Policy. and technical issues important to FDA
demonstrating safety and effectiveness and its mission, including emerging
[FR Doc. 2018–15296 Filed 7–17–18; 8:45 am]
for a nonprescription drug product in issues within the scientific community.
BILLING CODE 4164–01–P
cases where the DFL alone is not Additionally, the Science Board will
sufficient to ensure that the drug provide advice that supports the Agency
product can be used safely and in keeping pace with technical and
effectively in a nonprescription setting: scientific developments, including in

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Document Created: 2018-11-06 10:25:12
Document Modified: 2018-11-06 10:25:12

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
Action		Notice; renewal of advisory committee.
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.
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]
FR Citation		83 FR 33939

83 FR 33939 - Advisory Committee; Science Board to the Food and Drug Administration; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 138 (July 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration