83_FR_23784 83 FR 23685 - Advisory Committee; Blood Products Advisory Committee; Renewal

83 FR 23685 - Advisory Committee; Blood Products Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 99 (May 22, 2018)

Page Range23685-23686
FR Document2018-10848

The Food and Drug Administration (FDA) is announcing the renewal of the Blood 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 Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 13, 2020.

Federal Register, Volume 83 Issue 99 (Tuesday, May 22, 2018) 
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23685-23686]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1787]


Advisory Committee; Blood 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 Blood 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 Blood Products Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until May 13, 2020.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2020, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm. 
6268, Silver Spring, MD 20993-0002, 240-402-8054, 
[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 Blood Products Advisory Committee. The committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner.
    The Blood Products Advisory 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 shall consist of a core of 17 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of clinical and administrative medicine, hematology, immunology, 
blood banking, surgery, internal medicine, biochemistry, engineering, 
biological and physical sciences, biotechnology, computer technology, 
statistics, epidemiology, sociology/ethics, and other related 
professions. 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 one non-voting member who is identified with industry 
interests.
    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

[[Page 23686]]

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/BloodProductsAdvisoryCommittee/ucm121602.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 visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10848 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices 23685 and to restrict use of such information Respondents: Employers, Financial to authorized purposes. Institutions, Insurers, and Child Support Agencies ANNUAL BURDEN ESTIMATES Average Number of Information collection Number of burden Total burden responses per instrument respondents hours per hours respondent response Registration Screens ....................................................................................... 648 1 0.15 97.20 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND as required, any other product for which Hours: 97.20 HUMAN SERVICES FDA has regulatory responsibility. In compliance with the requirements The Committee shall consist of a core Food and Drug Administration of 17 voting members including the of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Chair. Members and the Chair are Administration for Children and [Docket No. FDA–2018–N–1787] selected by the Commissioner or designee from among authorities Families is soliciting public comment Advisory Committee; Blood Products knowledgeable in the fields of clinical on the specific aspects of the Advisory Committee; Renewal and administrative medicine, information collection described above. hematology, immunology, blood Copies of the proposed collection of AGENCY: Food and Drug Administration, HHS. banking, surgery, internal medicine, information can be obtained and biochemistry, engineering, biological comments may be forwarded by writing ACTION:Notice; renewal of advisory and physical sciences, biotechnology, to the Administration for Children and committee. computer technology, statistics, Families, Office of Planning, Research epidemiology, sociology/ethics, and SUMMARY: The Food and Drug and Evaluation, 330 C Street SW, Administration (FDA) is announcing the other related professions. Members will Washington DC 20201. Attn: ACF renewal of the Blood Products Advisory be invited to serve for overlapping terms Reports Clearance Officer. Email Committee by the Commissioner of of up to 4 years. Almost all non-Federal address: infocollection@acf.hhs.gov. All Food and Drugs (the Commissioner). members of this committee serve as requests should be identified by the title The Commissioner has determined that Special Government Employees. The of the information collection. it is in the public interest to renew the core of voting members may include one The Department specifically requests Blood Products Advisory Committee for technically qualified member, selected comments on: (a) Whether the proposed an additional 2 years beyond the charter by the Commissioner or designee, who collection of information is necessary expiration date. The new charter will be is identified with consumer interests in effect until May 13, 2020. and is recommended by either a for the proper performance of the DATES: Authority for the Blood Products consortium of consumer-oriented functions of the agency, including Advisory Committee will expire on May organizations or other interested whether the information shall have 13, 2020, unless the Commissioner persons. In addition to the voting practical utility; (b) the accuracy of the members, the Committee may include agency’s estimate of the burden of the formally determines that renewal is in the public interest. one non-voting member who is proposed collection of information; (c) identified with industry interests. the quality, utility, and clarity of the FOR FURTHER INFORMATION CONTACT: The Commissioner or designee shall information to be collected; and (d) Bryan Emery, Division of Scientific have the authority to select members of ways to minimize the burden of the Advisors and Consultants, Center for other scientific and technical FDA collection of information on Biologics Evaluation and Research, advisory committees (normally not to respondents, including through the use Food and Drug Administration, 10993 exceed 10 members) to serve of automated collection techniques or New Hampshire Ave., Bldg. 71, Rm. temporarily as voting members and to other forms of information technology. 6268, Silver Spring, MD 20993–0002, designate consultants to serve Consideration will be given to 240–402–8054, Bryan.emery@ temporarily as voting members when: comments and suggestions submitted fda.hhs.gov. (1) Expertise is required that is not within 60 days of this publication. SUPPLEMENTARY INFORMATION: Pursuant available among current voting standing to 41 CFR 102–3.65 and approval by the members of the Committee (when Robert Sargis, Department of Health and Human additional voting members are added to Reports Clearance Officer. Services pursuant to 45 CFR part 11 and the Committee to provide needed [FR Doc. 2018–10910 Filed 5–21–18; 8:45 am] by the General Services Administration, expertise, a quorum will be based on the BILLING CODE 4184–41–P FDA is announcing the renewal of the combined total of regular and added Blood Products Advisory Committee. members), or (2) to comprise a quorum The committee is a discretionary when, because of unforeseen amozie on DSK3GDR082PROD with NOTICES1 Federal advisory committee established circumstances, a quorum is or will be to provide advice to the Commissioner. lacking. Because of the size of the The Blood Products Advisory Committee and the variety in the types Committee advises the Commissioner or of issues that it will consider, FDA may, designee in discharging responsibilities in connection with a particular as they relate to helping to ensure safe committee meeting, specify a quorum and effective drugs for human use and, that is less than a majority of the current VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1

23686 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices voting members. The Agency’s (PMAs) that have been approved. This 5884, FDA–2017–M–5929, FDA–2017– regulations (21 CFR 14.22(d)) authorize list is intended to inform the public of M–5969, FDA–2017–M–5968, FDA– a committee charter to specify quorum the availability of safety and 2017–M–5997, FDA–2017–M–6223, requirements. effectiveness summaries of approved FDA–2017–M–6232, FDA–2017–M– If functioning as a medical device PMAs through the internet and the 6290, FDA–2017–M–6524, FDA–2017– panel, a non-voting representative of Agency’s Dockets Management Staff. M–6525, FDA–2017–M–6550, FDA– consumer interests and a non-voting ADDRESSES: You may submit comments 2017–M–6614, FDA–2017–M–6650, representative of industry interests will as follows: FDA–2017–M–6799, FDA–2017–M– be included in addition to the voting 6800, and FDA–2017–M–6896 for members. Electronic Submissions ‘‘Medical Devices; Availability of Safety Further information regarding the Submit electronic comments in the and Effectiveness Summaries for most recent charter and other following way: Premarket Approval Applications.’’ information can be found at https:// • Federal eRulemaking Portal: Received comments will be placed in www.fda.gov/AdvisoryCommittees/ httpss://www.regulations.gov. Follow the docket and, except for those CommitteesMeetingMaterials/Blood the instructions for submitting submitted as ‘‘Confidential VaccinesandOtherBiologics/ comments. Comments submitted Submissions,’’ publicly viewable at BloodProductsAdvisoryCommittee/ electronically, including attachments, to https://www.regulations.gov or at the ucm121602.htm or by contacting the https://www.regulations.gov will be Dockets Management Staff between 9 Designated Federal Officer (see FOR posted to the docket unchanged. a.m. and 4 p.m., Monday through FURTHER INFORMATION CONTACT). In light Because your comment will be made Friday. of the fact that no change has been made public, you are solely responsible for to the committee name or description of ensuring that your comment does not • Confidential Submissions—To duties, no amendment will be made to include any confidential information submit a comment with confidential 21 CFR 14.100. that you or a third party may not wish information that you do not wish to be This document is issued under the to be posted, such as medical made publicly available, submit your Federal Advisory Committee Act (5 information, your or anyone else’s comments only as a written/paper U.S.C. app.). For general information Social Security number, or confidential submission. You should submit two related to FDA advisory committees, business information, such as a copies total. One copy will include the please visit us at https://www.fda.gov/ manufacturing process. Please note that information you claim to be confidential AdvisoryCommittees/default.htm. if you include your name, contact with a heading or cover note that states information, or other information that ‘‘THIS DOCUMENT CONTAINS Dated: May 15, 2018. identifies you in the body of your CONFIDENTIAL INFORMATION.’’ The Leslie Kux, Agency will review this copy, including comments, that information will be Associate Commissioner for Policy. posted on https://www.regulations.gov. the claimed confidential information, in [FR Doc. 2018–10848 Filed 5–21–18; 8:45 am] • If you want to submit a comment its consideration of comments. The BILLING CODE 4164–01–P with confidential information that you second copy, which will have the do not wish to be made available to the claimed confidential information public, submit the comment as a redacted/blacked out, will be available DEPARTMENT OF HEALTH AND written/paper submission and in the for public viewing and posted on HUMAN SERVICES manner detailed (see ‘‘Written/Paper https://www.regulations.gov. Submit Submissions’’ and ‘‘Instructions’’). both copies to the Dockets Management Food and Drug Administration Written/Paper Submissions Staff. If you do not wish your name and [Docket Nos. FDA–2017–M–3372, FDA– contact information to be made publicly 2017–M–3951, FDA–2017–M–3990, FDA– Submit written/paper submissions as available, you can provide this 2017–M–4022, FDA–2017–M–4271, FDA– follows: information on the cover sheet and not 2017–M–4498, FDA–2017–M–4756, FDA– • Mail/Hand delivery/Courier (for in the body of your comments and you 2017–M–4757, FDA–2017–M–4711, FDA– written/paper submissions): Dockets 2017–M–4904, FDA–2017–M–5320, FDA– must identify this information as Management Staff (HFA–305), Food and ‘‘confidential.’’ Any information marked 2017–M–5262, FDA–2017–M–5334, FDA– Drug Administration, 5630 Fishers 2017–M–5438, FDA–2017–M–5813, FDA– as ‘‘confidential’’ will not be disclosed Lane, Rm. 1061, Rockville, MD 20852. except in accordance with 21 CFR 10.20 2017–M–5863, FDA–2017–M–5864, FDA– • For written/paper comments 2017–M–5884, FDA–2017–M–5929, FDA– and other applicable disclosure law. For 2017–M–5969, FDA–2017–M–5968, FDA– submitted to the Dockets Management more information about FDA’s posting 2017–M–5997, FDA–2017–M–6223, FDA– Staff, FDA will post your comment, as of comments to public dockets, see 80 2017–M–6232, FDA–2017–M–6290, FDA– well as any attachments, except for FR 56469, September 18, 2015, or access 2017–M–6524, FDA–2017–M–6525, FDA– information submitted, marked and the information at: https://www.gpo.gov/ 2017–M–6550, FDA–2017–M–6614, FDA– identified, as confidential, if submitted 2017–M–6650, FDA–2017–M–6799, FDA– as detailed in ‘‘Instructions.’’ fdsys/pkg/FR-2015-09-18/pdf/2015- 2017–M–6800, and FDA–2017–M–6896] Instructions: All submissions received 23389.pdf. must include the Docket Nos. FDA– Docket: For access to the docket to Medical Devices; Availability of Safety 2017–M–3372, FDA–2017–M–3951, read background documents or the and Effectiveness Summaries for FDA–2017–M–3990, FDA–2017–M– electronic and written/paper comments Premarket Approval Applications 4022, FDA–2017–M–4271, FDA–2017– received, go to https:// amozie on DSK3GDR082PROD with NOTICES1 AGENCY: Food and Drug Administration, M–4498, FDA–2017–M–4756, FDA– www.regulations.gov and insert the HHS. 2017–M–4757, FDA–2017–M–4711, docket number, found in brackets in the ACTION: Notice. FDA–2017–M–4904, FDA–2017–M– heading of this document, into the 5320, FDA–2017–M–5262, FDA–2017– ‘‘Search’’ box and follow the prompts SUMMARY: The Food and Drug M–5334, FDA–2017–M–5438, FDA– and/or go to the Dockets Management Administration (FDA) is publishing a 2017–M–5813, FDA–2017–M–5863, Staff, 5630 Fishers Lane, Rm. 1061, list of premarket approval applications FDA–2017–M–5864, FDA–2017–M– Rockville, MD 20852. 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Document Created: 2018-11-02 11:09:55
Document Modified: 2018-11-02 11:09:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; renewal of advisory committee.
DatesAuthority for the Blood Products Advisory Committee will expire on May 13, 2020, unless the Commissioner formally determines that renewal is in the public interest.
ContactBryan Emery, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-402-8054, [email protected]
FR Citation83 FR 23685 
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