Advisory Committee; Blood Products Advisory Committee; Renewal, 47427-47428 [2022-16577]

Download as PDF Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Active Ingredient(s) Cetirizine hydrochloride Dantrolene sodium Ethinyl estradiol; Norethindrone Ethinyl estradiol; Norethindrone acetate Lamotrigine Lanthanum carbonate Loratadine Medroxyprogesterone acetate (multiple reference listed drugs) Meloxicam Methylphenidate hydrochloride Nicotine Olopatadine hydrochloride Oxymetazone hydrochloride; Tetracaine hydrochloride Prednisone Tacrolimus Upadacitinib [Docket No. FDA–2022–N–0008] Advisory Committee; Blood Products Advisory Committee; Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of Federal advisory committee. ACTION: For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 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 the May 13, 2024, expiration date. DATES: Authority for the Blood Products Advisory Committee will expire on May 13, 2024, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver Spring, MD 20993–0002, 240–402–8054, Christina.Vert@ fda.hhs.gov. IV. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION: FDA tentatively concludes that these draft guidances contain no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. lotter on DSK11XQN23PROD with NOTICES1 Food and Drug Administration Dated: July 27, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–16502 Filed 8–2–22; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:39 Aug 02, 2022 Jkt 256001 SUMMARY: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Blood 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 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 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 the Food and Drug Administration has regulatory responsibility. The Committee also PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 47427 advises the Commissioner of Food and Drugs 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: (1) recommends classification of devices subject to its review into regulatory categories; (2) recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category; (3) advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate; (4) recommends exemption of certain devices from the application of portions of the Medical Device Amendments of 1976; (5) advises on the necessity to ban a device; and (6) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. 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. Non-Federal members of this committee will serve as Special Government Employees, representatives, or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. 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 consumeroriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry E:\FR\FM\03AUN1.SGM 03AUN1 47428 Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 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 most 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, an additional non-voting representative member of consumer interests and an additional non-voting representative member 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/advisory-committees/ blood-vaccines-and-other-biologics/ blood-products-advisory-committee 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 notice 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: July 28, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–16577 Filed 8–2–22; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:39 Aug 02, 2022 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–1625] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-BUTINACA; Adinazolam; Bromazolam; Protonitazene (Propoxynitazene); Etazene (Etodesnitazene); Etonitazepyne (N-Pyrrolidino etonitazene); 2-Methyl-AP-237; AlphaPiHP; 3-Methylmethcathinone (3-MMC); Zopiclone; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA or Agency) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA). DATES: Either electronic or written comments must be submitted by August 24, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 24, 2022. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. SUMMARY: 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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– 2022–N–1625 for ‘‘International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADBBUTINACA; Adinazolam; Bromazolam; Protonitazene (propoxynitazene); Etazene (etodesnitazene); Etonitazepyne (N-pyrrolidino etonitazene); 2-MethylAP-237; alpha-PiHP; 3Methylmethcathinone (3-MMC); Zopiclone; Request for Comments’’ Received comments, those filed in a timely manner (see ADDRESSES), 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, 240–402–7500. • 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.’’ The Agency will review this copy, including E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47427-47428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]


Advisory Committee; Blood Products Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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

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 the May 13, 2024, expiration 
date.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2024, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
1244, 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 and by the General Services 
Administration, FDA is announcing the renewal of the Blood 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 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 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 the Food and Drug Administration 
has regulatory responsibility. The Committee also advises the 
Commissioner of Food and Drugs 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: (1) recommends classification of devices subject to its 
review into regulatory categories; (2) recommends the assignment of a 
priority for the application of regulatory requirements for devices 
classified in the standards or premarket approval category; (3) advises 
on formulation of product development protocols and reviews premarket 
approval applications for those devices to recommend changes in 
classification as appropriate; (4) recommends exemption of certain 
devices from the application of portions of the Medical Device 
Amendments of 1976; (5) advises on the necessity to ban a device; and 
(6) responds to requests from the Agency to review and make 
recommendations on specific issues or problems concerning the safety 
and effectiveness of devices.
    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. Non-Federal members of this committee will serve as 
Special Government Employees, representatives, or Ex-Officio members. 
Federal members will serve as Regular Government Employees or Ex-
Officios. 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 representative member who is identified with industry

[[Page 47428]]

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 most 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, an additional non-voting 
representative member of consumer interests and an additional non-
voting representative member 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/advisory-committees/blood-vaccines-and-other-biologics/blood-products-advisory-committee 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 notice 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: July 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16577 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P

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