Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee, 36594-36595 [2020-13042]

Download as PDF 36594 Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices both copies to the Dockets Management Staff. If you do not wish your name and contact information to 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 this 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: khammond on DSKJM1Z7X2PROD with NOTICES Sana F. Hussain, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: II. Paperwork Reduction Act of 1995 I. Background FDA is announcing the availability of a guidance entitled ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ This document was posted on FDA’s website on April 2, 2020 (see section III for electronic access to the guidance). The guidance provides blood establishments that collect blood VerDate Sep<11>2014 16:44 Jun 16, 2020 Jkt 250001 and blood components with revised recommendations intended to reduce the possible risk of transmission of CJD and vCJD by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. FDA is revising or removing our prior recommendations to screen blood donors for: (1) Geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on U.S. military bases in Europe; (2) receipt of a blood transfusion in certain vCJD risk countries; (3) risk factors for iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-derived growth hormone); (4) having blood relatives with CJD; and (5) a history of injecting bovine insulin. In the Federal Register of January 31, 2020 (85 FR 5668), FDA announced the availability of the draft guidance of the same title dated January 2020. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Based on these comments, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated January 2020, and supersedes the document entitled ‘‘Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,’’ dated May 2010, and updated January 2016. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on recommendations to reduce the possible risk of transmission of CJD and vCJD by blood and blood components. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The collections of information in 21 CFR 601.12 and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR parts 610 and PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 630 have been approved under OMB control number 0910–0116. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances or https:// www.regulations.gov. Dated: June 12, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–13055 Filed 6–16–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0965] Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (the Committee), Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. DATES: Nominations received on or before August 17, 2020, will be given first consideration for membership on the Pharmacy Compounding Advisory Committee. Nominations received after August 17, 2020, will be considered for nominations to the Committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA Advisory Committee Nomination Portal: https://www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1 Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices MD 20993–0002. 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/ default.htm. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is: Yvette Waples, 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: PCAC@fda.hhs.gov. 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. FDA is requesting nominations for voting members on the Pharmacy Compounding Advisory Committee. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES I. General Description of the Committee’s Duties The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under sections 503A and 503B of the FD&C Act (21 U.S.C 353a and 353b), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. In implementing sections 503A and section 503B of the FD&C Act, the Agency may consult the Committee on: (1) Drug products for inclusion on a list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective, and therefore cannot be compounded; (2) bulk drug substances for inclusion on lists of bulk drug substances that may be used in compounding; and (3) drug products for inclusion on a list of drug products that present demonstrable difficulties for compounding. Meetings are held approximately one to two times a year, announced in the Federal Register, and are open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act (Pub. L. 92–463). Notice of all meetings shall be given to the public. VerDate Sep<11>2014 16:44 Jun 16, 2020 Jkt 250001 II. Criteria for Voting Members The Committee consists of a core of 12 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. These members will include representatives from the National Association of Boards of Pharmacy, the U.S. Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. 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 individuals 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 and/or home address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Nomination Portal (see ADDRESSES). Nominations must also 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 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: June 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–13042 Filed 6–16–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 36595 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1211] Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.’’ The revised guidance provides blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to their donor educational materials, donor history questionnaires, and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance also incorporates certain other recommendations related to donor educational materials. The guidance announced in this notice supersedes the guidance of the same title dated December 2015. DATES: The announcement of the guidance is published in the Federal Register on June 17, 2020. The Agency is soliciting public comment, but is implementing this guidance immediately, because the Agency has determined that prior public participation is not feasible or appropriate. Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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:// E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36594-36595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0965]


Request for Nominations for Voting Members on a Public Advisory 
Committee; Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
requesting nominations for members to serve on the Pharmacy Compounding 
Advisory Committee (the Committee), Division of Advisory Committee and 
Consultant Management, Center for Drug Evaluation and Research. The 
Committee provides advice on scientific, technical, and medical issues 
concerning human drug compounding under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), and, as required, any other product for which 
FDA has regulatory responsibility, and makes appropriate 
recommendations to the Commissioner of Food and Drugs.

DATES: Nominations received on or before August 17, 2020, will be given 
first consideration for membership on the Pharmacy Compounding Advisory 
Committee. Nominations received after August 17, 2020, will be 
considered for nominations to the Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Committee Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail 
to Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring,

[[Page 36595]]

MD 20993-0002. 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/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is: Yvette Waples, 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: [email protected].

SUPPLEMENTARY INFORMATION: 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.
    FDA is requesting nominations for voting members on the Pharmacy 
Compounding Advisory Committee.

I. General Description of the Committee's Duties

    The Committee provides advice on scientific, technical, and medical 
issues concerning human drug compounding under sections 503A and 503B 
of the FD&C Act (21 U.S.C 353a and 353b), and, as required, any other 
product for which FDA has regulatory responsibility, and makes 
appropriate recommendations to the Commissioner of Food and Drugs.
    In implementing sections 503A and section 503B of the FD&C Act, the 
Agency may consult the Committee on: (1) Drug products for inclusion on 
a list of drug products that have been withdrawn or removed from the 
market because such drug products or components of such drug products 
have been found to be unsafe or not effective, and therefore cannot be 
compounded; (2) bulk drug substances for inclusion on lists of bulk 
drug substances that may be used in compounding; and (3) drug products 
for inclusion on a list of drug products that present demonstrable 
difficulties for compounding.
    Meetings are held approximately one to two times a year, announced 
in the Federal Register, and are open to the public except as 
determined otherwise by the Commissioner or designee in accordance with 
the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal 
Advisory Committee Act (Pub. L. 92-463). Notice of all meetings shall 
be given to the public.

II. Criteria for Voting Members

    The Committee consists of a core of 12 voting members including the 
Chair. Members and the Chair are selected by the Commissioner or 
designee from among authorities knowledgeable in the fields of 
pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, 
medicine, and related specialties. These members will include 
representatives from the National Association of Boards of Pharmacy, 
the U.S. Pharmacopeia, pharmacists with current experience and 
expertise in compounding, physicians with background and knowledge in 
compounding, and patient and public health advocacy organizations. 
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 
individuals 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 and/or home address, telephone number, and 
email address if available, and a signed copy of the Acknowledgement 
and Consent form available at the FDA Advisory Committee Nomination 
Portal (see ADDRESSES). Nominations must also 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 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: June 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13042 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P

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