Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee, 43141-43142 [2019-17924]

Download as PDF Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices 2. Toxicology studies including Pharmacokinetic Concentrations Domain (PC) and Pharmacokinetics Parameters Domain (PP) domains. 3. Toxicology studies with study data using controlled terminology (version 2018–03–30 or later) for: a. Severity. b. Non-neoplasm (NONNEO) using codelist NONNEO and Microscopic Domain (MI). Please indicate in your request for participation the extent to which your submission will meet the above listed criteria. This pilot is intended to inform on the readiness of the SEND 3.1 standard and support improvements to the SENDIG 3.1 that will benefit FDA and submitters. Pilot participants commit to publicly share lessons learned with the CDISC SEND team to ensure that the CDISC SEND standard is improved for the community. Participants may redact any sensitive information as needed to enable sharing FDA feedback with the CDISC SEND team. III. Requests for Participation Requests to participate in the SENDIG 3.1 FFU pilot are to be identified with the docket number found in brackets in the heading of this document. Interested persons should include the following information in the request: Contact name, contact phone number, email address, name of the sponsor, address, and license number, as well as the description of criteria met, addressing each of the items in the II. Project Participation section. Once requests for participation are received, CDER will contact interested sponsors to discuss the pilot project and clarify requirements and expectations. The elapsed time duration of the pilot is expected to be approximately 6 months but may be extended as needed. Dated: August 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–17877 Filed 8–19–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jbell on DSK3GLQ082PROD with NOTICES [Docket No. FDA–2019–N–0573] Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 20:49 Aug 19, 2019 Jkt 247001 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Blood Products Advisory Committee (the Committee) in the Center for Biologics Evaluation and Research. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before October 21, 2019 will be given first consideration for membership on the Blood Products Advisory Committee. Nominations received after October 21, 2019 will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA Advisory Nomination Portal: https:// www.accessdata.fda.gov/scripts/ factrsportal/factrs/index.cfm. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https://www.fda.gov/advisorycommittees. FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993–0002, 240– 402–8054, Fax: 301–595–1309, email: Christina.Vert@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members to fill upcoming vacancies on the Blood Products Advisory Committee. I. General Description of the Committee Duties The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs (the Commissioner) of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 43141 studies involving such products, on the affirmation or revocation of biological products licenses, and on the quality and relevance of FDA’s research program which provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee recommends classification of devices subject to its review into regulatory categories; recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category; advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. II. Criteria for Voting Members The Committee consists 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. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee, including current business address, telephone number, and email address if available and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask E:\FR\FM\20AUN1.SGM 20AUN1 43142 Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: August 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–17924 Filed 8–19–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3613] Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. jbell on DSK3GLQ082PROD with NOTICES ACTION: SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on October 16, 2019, from 8:00 a.m. to 4:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2019–N–3613. The docket will close on October 15, 2019. Submit either electronic or written comments on this public meeting by October 15, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or VerDate Sep<11>2014 20:49 Aug 19, 2019 Jkt 247001 before October 15, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 15, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before October 1, 2019, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments 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– 2019–N–3613 for ‘‘Antimicrobial Drugs PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments, those filed in a timely manner (see the ADDRESSES section), 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 submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lauren Tesh Hotaki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: AMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– E:\FR\FM\20AUN1.SGM 20AUN1

Agencies

[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43141-43142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17924]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Blood Products Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the Blood Products Advisory 
Committee (the Committee) in the Center for Biologics Evaluation and 
Research. Nominations will be accepted for upcoming vacancies effective 
with this notice. FDA seeks to include the views of women and men, 
members of all racial and ethnic groups, and individuals with and 
without disabilities on its advisory committees and, therefore 
encourages nominations of appropriately qualified candidates from these 
groups.

DATES: Nominations received on or before October 21, 2019 will be given 
first consideration for membership on the Blood Products Advisory 
Committee. Nominations received after October 21, 2019 will be 
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's website at https://www.fda.gov/advisory-committees.

FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, Fax: 301-595-1309, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to fill upcoming vacancies on the Blood Products Advisory 
Committee.

I. General Description of the Committee Duties

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of blood, products derived 
from blood and serum or biotechnology which are intended for use in the 
diagnosis, prevention, or treatment of human diseases, and, as 
required, any other product for which FDA has regulatory 
responsibility, and advises the Commissioner of Food and Drugs (the 
Commissioner) of its findings regarding screening and testing (to 
determine eligibility) of donors and labeling of the products, on 
clinical and laboratory studies involving such products, on the 
affirmation or revocation of biological products licenses, and on the 
quality and relevance of FDA's research program which provides the 
scientific support for regulating these agents. The Committee will 
function at times as a medical device panel under the Federal Food, 
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the 
Committee recommends classification of devices subject to its review 
into regulatory categories; recommends the assignment of a priority for 
the application of regulatory requirements for devices classified in 
the standards or premarket approval category; advises on formulation of 
product development protocols and reviews premarket approval 
applications for those devices to recommend changes in classification 
as appropriate; recommends exemption of certain devices from the 
application of portions of the Act; advises on the necessity to ban a 
device; and responds to requests from the Agency to review and make 
recommendations on specific issues or problems concerning the safety 
and effectiveness of devices.

II. Criteria for Voting Members

    The Committee consists 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. Almost 
all non-Federal members of this committee serve as Special Government 
Employees. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified persons 
for membership on the advisory committee. Self-nominations are also 
accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including 
current business address, telephone number, and email address if 
available and a signed copy of the Acknowledgement and Consent form 
available at the FDA Advisory Nomination Portal (see ADDRESSES). 
Nominations must specify the advisory committee for which the nominee 
is recommended. Nominations must also acknowledge that the nominee is 
aware of the nomination unless self-nominated. FDA will ask

[[Page 43142]]

potential candidates to provide detailed information concerning such 
matters related to financial holdings, employment, and research grants 
and/or contracts to permit evaluation of possible sources of conflicts 
of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17924 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P

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