83 FR 32310 - Advisory Committee; Allergenic Products Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 134 (July 12, 2018)

Page Range		32310-32311
FR Document		2018-14942

The Food and Drug Administration (FDA) is announcing the renewal of the Allergenic Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 9, 2020.

Federal Register, Volume 83 Issue 134 (Thursday, July 12, 2018)

[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32310-32311]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14942]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2475]

Advisory Committee; Allergenic Products Advisory Committee;
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Allergenic Products Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Allergenic
Products Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until July
9, 2020.

DATES: Authority for the Allergenic Products Advisory Committee expired
on July 9, 2018; however, the Commissioner formally determined that
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002; 240-402-5771,
serina.hunter-thomas@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 Allergenic Products Advisory Committee. The committee is
a discretionary Federal advisory committee established to provide
advice to the Commissioner. The committee 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 Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of its findings regarding the affirmation or
revocation of biological product licenses; on the safety,
effectiveness, and labeling of the products; on clinical and laboratory
studies of such products; on amendments or revisions to regulations
governing the manufacture, testing, and licensing of allergenic
biological products; and on the quality and relevance of FDA's research
programs that provide the scientific support for regulating these
agents.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of allergy, immunology, pediatrics, internal medicine,
biochemistry, and related specialties. 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. In addition to the
voting members, the Committee may include

[[Page 32311]]

one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm129360.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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14942 Filed 7-11-18; 8:45 am]
BILLING CODE 4164-01-P

32310 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Silver Spring, MD 20993–0002, 240– regulations. This guidance is not subject Scientific Advisors and Consultants,
402–7911. to Executive Order 12866. Center for Biologics Evaluation and
Research, Food and Drug
SUPPLEMENTARY INFORMATION: II. Paperwork Reduction Act of 1995
Administration, 10903 New Hampshire
I. Background The draft guidance refers to Ave., Bldg. 71, Rm. 6338, Silver Spring,
previously approved collections of MD 20993–0002; 240–402–5771,
FDA is announcing the availability of information found in FDA regulations. serina.hunter-thomas@fda.hhs.gov.
a draft document entitled ‘‘Testing of These collections of information are SUPPLEMENTARY INFORMATION: Pursuant
Retroviral Vector-Based Human Gene subject to review by the Office of to 41 CFR 102–3.65 and approval by the
Therapy Products for Replication Management and Budget (OMB) under Department of Health and Human
Competent Retrovirus During Product the Paperwork Reduction Act of 1995 Services pursuant to 45 CFR part 11 and
Manufacture and Patient Follow-up; (44 U.S.C. 3501–3520). The collections by the General Services Administration,
Draft Guidance for Industry.’’ The draft of information in 21 CFR part 312 have FDA is announcing the renewal of the
guidance document provides sponsors been approved under OMB control Allergenic Products Advisory
of retroviral vector-based human gene number 0910–0014; and the collections Committee. The committee is a
therapy products recommendations of information in 21 CFR part 601 have discretionary Federal advisory
regarding the testing for RCR during the been approved under OMB control committee established to provide advice
manufacture of retroviral vector-based number 0910–0338. to the Commissioner. The committee
products, and during follow-up advises the Commissioner or designee
III. Electronic Access
monitoring of patients who have in discharging responsibilities as they
received retroviral vector-based Persons with access to the internet relate to helping to ensure safe and
products. Recommendations are also may obtain the draft guidance at either effective drugs for human use and, as
provided for RCR testing during https://www.fda.gov/BiologicsBlood required, any other product for which
manufacture, including identification Vaccines/GuidanceCompliance FDA has regulatory responsibility.
and amount of material to be tested, and RegulatoryInformation/Guidances/ The Committee reviews and evaluates
general testing methods. In addition, default.htm or https:// available data concerning the safety,
recommendations are provided on www.regulations.gov. effectiveness, and adequacy of labeling
monitoring patients for evidence of Dated: July 5, 2018. of marketed and investigational
retroviral infection after administration Leslie Kux, allergenic biological products or
of retroviral vector-based gene therapy Associate Commissioner for Policy. materials that are administered to
products. The draft guidance, when humans for the diagnosis, prevention, or
[FR Doc. 2018–14868 Filed 7–11–18; 8:45 am]
finalized, is intended to supersede the treatment of allergies and allergic
BILLING CODE 4164–01–P
document entitled ‘‘Guidance for disease, and makes appropriate
Industry: Supplemental Guidance on recommendations to the Commissioner
Testing for Replication Competent DEPARTMENT OF HEALTH AND of its findings regarding the affirmation
Retrovirus in Retroviral Vector Based HUMAN SERVICES or revocation of biological product
Gene Therapy Products and During licenses; on the safety, effectiveness,
Follow-up of Patients in Clinical Trials Food and Drug Administration and labeling of the products; on clinical
Using Retroviral Vectors,’’ dated and laboratory studies of such products;
November 2006. The draft guidance, [Docket No. FDA–2018–N–2475]
on amendments or revisions to
when finalized, is also intended to regulations governing the manufacture,
Advisory Committee; Allergenic
supplement the ‘‘Long Term Follow-Up testing, and licensing of allergenic
Products Advisory Committee;
After Administration of Human Gene biological products; and on the quality
Renewal
Therapy Products; Draft Guidance for and relevance of FDA’s research
Industry’’ and ‘‘Chemistry, AGENCY: Food and Drug Administration, programs that provide the scientific
Manufacturing, and Control Information HHS. support for regulating these agents.
for Human Gene Therapy ACTION:Notice; renewal of advisory The Committee shall consist of a core
Investigational New Drug Applications; committee. of nine voting members including the
Draft Guidance for Industry,’’ when Chair. Members and the Chair are
these draft guidance documents are SUMMARY: The Food and Drug selected by the Commissioner or
finalized. Elsewhere in this issue of the Administration (FDA) is announcing the designee from among authorities
Federal Register, FDA is announcing renewal of the Allergenic Products knowledgeable in the fields of allergy,
the availability of these other two draft Advisory Committee by the immunology, pediatrics, internal
guidance documents. Commissioner of Food and Drugs (the medicine, biochemistry, and related
This draft guidance is being issued Commissioner). The Commissioner has specialties. Members will be invited to
consistent with FDA’s good guidance determined that it is in the public serve for overlapping terms of up to 4
practices regulation (21 CFR 10.115). interest to renew the Allergenic years. Almost all non-Federal members
The draft guidance, when finalized, will Products Advisory Committee for an of this committee serve as Special
represent FDA’s current thinking on additional 2 years beyond the charter Government Employees. The core of
testing of retroviral vector-based human expiration date. The new charter will be voting members may include one
gene therapy products for replication in effect until July 9, 2020. technically qualified member, selected
amozie on DSK3GDR082PROD with NOTICES1

competent retrovirus during product DATES: Authority for the Allergenic by the Commissioner or designee, who
manufacture and patient follow-up. It Products Advisory Committee expired is identified with consumer interests
does not establish any rights for any on July 9, 2018; however, the and is recommended by either a
person and is not binding on FDA or the Commissioner formally determined that consortium of consumer-oriented
public. You can use an alternative renewal is in the public interest. organizations or other interested
approach if it satisfies the requirements FOR FURTHER INFORMATION CONTACT: persons. In addition to the voting
of the applicable statutes and Serina Hunter-Thomas, Division of members, the Committee may include

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Document Created: 2018-11-06 10:22:42
Document Modified: 2018-11-06 10:22:42

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
Action		Notice; renewal of advisory committee.
Dates		Authority for the Allergenic Products Advisory Committee expired on July 9, 2018; however, the Commissioner formally determined that renewal is in the public interest.
Contact		Serina Hunter-Thomas, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002; 240-402-5771, [email protected]
FR Citation		83 FR 32310

83 FR 32310 - Advisory Committee; Allergenic Products Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 134 (July 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration