83 FR 1262 - Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 7 (January 10, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 7 (January 10, 2018)
| Page Range | 1262-1262 | |
| FR Document | 2018-00239 |
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)] [Notices] [Page 1262] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00239] [[Page 1262]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6827] Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. ACTION: Notice; renewal of advisory committee. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the renewal of the Vaccines and Related Biological 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 Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 31, 2019. DATES: Authority for the Vaccines and Related Biological Products Advisory Committee will expire on December 31, 2019, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Division of Scientific Advisors and Consultants, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993- 0002, 240-402-5771, [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 Vaccines and Related Biological Products Advisory Committee (the 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 vaccines and related biological products for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which FDA has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program, which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner. The Committee shall consist of a core of 15 voting members, including the Chairperson (the Chair). Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. 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. Ex Officio voting members one each from the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the National Institutes of Health may be included. 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 one non-voting member who is identified with industry interests. There may also be an alternate industry representative. 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/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.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: January 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00239 Filed 1-9-18; 8:45 am] BILLING CODE 4164-01-P
![1262 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
DEPARTMENT OF HEALTH AND other products for which FDA has that is less than a majority of the current
HUMAN SERVICES regulatory responsibility. The voting members. The Agency’s
Committee also considers the quality regulations (21 CFR 14.22(d)) authorize
Food and Drug Administration and relevance of FDA’s research a committee charter to specify quorum
[Docket No. FDA–2017–N–6827] program, which provides scientific requirements.
support for the regulation of these If functioning as a medical device
Advisory Committee; Vaccines and products and makes appropriate panel, a non-voting representative of
Related Biological Products Advisory recommendations to the Commissioner. consumer interests and a non-voting
Committee, Renewal The Committee shall consist of a core representative of industry interests will
of 15 voting members, including the be included in addition to the voting
AGENCY: Food and Drug Administration, Chairperson (the Chair). Members and members.
HHS. the Chair are selected by the Further information regarding the
ACTION:Notice; renewal of advisory Commissioner or designee from among most recent charter and other
committee. authorities knowledgeable in the fields information can be found at: https://
of immunology, molecular biology, www.fda.gov/AdvisoryCommittees/
SUMMARY: The Food and Drug rDNA, virology, bacteriology, CommitteesMeetingMaterials/Blood
Administration (FDA) is announcing the epidemiology or biostatistics, vaccine VaccinesandOtherBiologics/
renewal of the Vaccines and Related policy, vaccine safety science, federal VaccinesandRelatedBiologicalProducts
Biological Products Advisory immunization activities, vaccine AdvisoryCommittee/ucm129571.htm or
Committee by the Commissioner of development including translational by contacting the Designated Federal
Food and Drugs (the Commissioner). and clinical evaluation programs, Officer (see FOR FURTHER INFORMATION
The Commissioner has determined that allergy, preventive medicine, infectious CONTACT). In light of the fact that no
it is in the public interest to renew the diseases, pediatrics, microbiology, and change has been made to the committee
Vaccines and Related Biological biochemistry. Members will be invited name or description of duties, no
Products Advisory Committee for an to serve for overlapping terms of up to amendment will be made to 21 CFR
additional 2 years beyond the charter 4 years. Almost all non-Federal 14.100. This document is issued under
expiration date. The new charter will be members of this committee serve as the Federal Advisory Committee Act (5
in effect until December 31, 2019. Special Government Employees. Ex U.S.C. app.). For general information
DATES: Authority for the Vaccines and Officio voting members one each from related to FDA advisory committees,
Related Biological Products Advisory the Department of Health and Human please check https://www.fda.gov/
Committee will expire on December 31, Services, the Centers for Disease Control AdvisoryCommittees/default.htm.
2019, unless the Commissioner formally and Prevention, and the National
Dated: January 4, 2018.
determines that renewal is in the public Institutes of Health may be included.
The core of voting members may Leslie Kux,
interest.
include one technically qualified Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of member, selected by the Commissioner [FR Doc. 2018–00239 Filed 1–9–18; 8:45 am]
Scientific Advisors and Consultants, or designee, who is identified with BILLING CODE 4164–01–P
Food and Drug Administration, 10903 consumer interests and is recommended
New Hampshire Ave., Bldg. 71, Rm. by either a consortium of consumer-
6338, Silver Spring, MD 20993–0002, oriented organizations or other DEPARTMENT OF HEALTH AND
240–402–5771, serina.hunter-thomas@ interested persons. In addition to the HUMAN SERVICES
fda.hhs.gov. voting members, the Committee may
include one non-voting member who is Food and Drug Administration
SUPPLEMENTARY INFORMATION: Pursuant identified with industry interests. There [Docket No. FDA–2008–N–0312]
to 41 CFR 102–3.65 and approval by the may also be an alternate industry
Department of Health and Human representative. Agency Information Collection
Services pursuant to 45 CFR part 11 and The Commissioner or designee shall Activities; Submission for Office of
by the General Services Administration, have the authority to select members of Management and Budget Review;
FDA is announcing the renewal of the other scientific and technical FDA Extralabel Drug Use in Animals
Vaccines and Related Biological advisory committees (normally not to
Products Advisory Committee (the exceed 10 members) to serve AGENCY: Food and Drug Administration,
Committee). The Committee is a temporarily as voting members and to HHS.
discretionary Federal advisory designate consultants to serve ACTION: Notice.
committee established to provide advice temporarily as voting members when:
to the Commissioner. The Committee (1) Expertise is required that is not SUMMARY: The Food and Drug
advises the Commissioner or designee available among current voting standing Administration (FDA or we) is
in discharging responsibilities as they members of the Committee (when announcing that a proposed collection
relate to helping to ensure safe and additional voting members are added to of information has been submitted to the
effective vaccines and related biological the Committee to provide needed Office of Management and Budget
products for human use and, as expertise, a quorum will be based on the (OMB) for review and clearance under
required, any other product for which combined total of regular and added the Paperwork Reduction Act of 1995.
FDA has regulatory responsibility. members) or (2) to comprise a quorum DATES: Fax written comments on the
daltland on DSKBBV9HB2PROD with NOTICES
The Committee reviews and evaluates when, because of unforeseen collection of information by February 9,
data concerning the safety, circumstances, a quorum is or will be 2018.
effectiveness, and appropriate use of lacking. Because of the size of the ADDRESSES: To ensure that comments on
vaccines and related biological products Committee and the variety in the types the information collection are received,
which are intended for use in the of issues that it will consider, FDA may, OMB recommends that written
prevention, treatment, or diagnosis of in connection with a particular comments be faxed to the Office of
human diseases, and, as required, any committee meeting, specify a quorum Information and Regulatory Affairs,
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Document Created: 2018-10-26 09:33:18
Document Modified: 2018-10-26 09:33:18
| 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 Vaccines and Related Biological Products Advisory Committee will expire on December 31, 2019, unless the Commissioner formally determines that renewal is in the public interest. | |
| Contact | Serina Hunter-Thomas, Division of Scientific Advisors and Consultants, 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 1262 |
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