Pharmacy Compounding Advisory Committee; Notice of Meeting, 35782-35783 [2016-13169]

Download as PDF 35782 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993–0002, or the Office of Communication, and Education, (CDRH), Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: mstockstill on DSK3G9T082PROD with NOTICES Regarding the draft guidance: Christian Grimstein, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3116, Silver Spring, MD 20993–0002, 301–796–5189; or Eunice Lee, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5546, Silver Spring, MD 20993–0002, 301– 796–4808. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1128, Silver Spring, MD 20993– 0002, 301–796–4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with VerDate Sep<11>2014 21:20 Jun 02, 2016 Jkt 238001 harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CDRH, FDA; and the Pharmaceutical Research and Manufacturers of America. The standing members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the members of the ICH Association. The ICH Assembly includes representatives from each of the ICH members, as well as observers from the World Health Organization and Drug Regulatory Authorities and Regional Harmonization Initiatives from around the world. In December 2015, the ICH Assembly endorsed the draft guidance entitled ‘‘E18 Genomic Sampling and Management of Genomic Data’’ and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Efficacy Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Efficacy Expert Working Group. The draft guidance provides guidance on genomic sampling and management of genomic data from interventional and non-interventional clinical studies. The draft guidance addresses use of genomic samples and data irrespective of the timing of analyses and both prespecified and non-pre-specified use. The focus is on the general principles of collecting, processing, transporting, storing and disposing of genomic samples or data, within the scope of an informed consent. The technical aspects of genomic sampling and research are also discussed when appropriate, recognizing the rapidly evolving technological advances in these areas. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘E18 Genomic Sampling and Management of Genomic Data.’’ 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/MedicalDevices/device regulationandguidance/guidance documents/default.htm. Dated: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13168 Filed 6–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Pharmacy Compounding Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee. The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Agency. The meeting will be open to the public. DATES: The meeting will be held on June 23, 2016, from 8:30 a.m. to 5 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/ AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, SUMMARY: E:\FR\FM\03JNN1.SGM 03JNN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: PCAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice (CGMP)); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list (the ‘‘section 503A bulk drug substances list’’) developed by the Secretary through regulations issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act). FDA will discuss with the committee drugs proposed for inclusion on the section 503A bulk drug substances list. Agenda: The committee intends to discuss six bulk drug substances nominated for inclusion on the section VerDate Sep<11>2014 21:20 Jun 02, 2016 Jkt 238001 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 15, 2016. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 9:40 a.m., 10:35 a.m. and 10:45 a.m., 11:40 a.m. and 11:50 a.m., 2:15 p.m. and 2:25 p.m., 3:20 p.m. and 3:30 p.m., and 4:40 p.m. and 4:50 p.m. Those individuals interested in making formal oral presentations should notify Cindy Hong and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 10, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 13, 2016. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 35783 FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Hong at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13169 Filed 6–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq. provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to SUMMARY: E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35782-35783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pharmacy Compounding Advisory 
Committee. The general function of the committee is to provide advice 
on scientific, technical, and medical issues concerning drug 
compounding under sections 503A and 503B of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), and, as required, any other product for which 
FDA has regulatory responsibility, and make appropriate recommendations 
to the Agency. The meeting will be open to the public.

DATES: The meeting will be held on June 23, 2016, from 8:30 a.m. to 5 
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/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring,

[[Page 35783]]

MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: 
PCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area). A notice in the 
Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes 
the conditions that must be satisfied for human drug products 
compounded by a licensed pharmacist or licensed physician to be exempt 
from the following three sections of the FD&C Act: (1) Section 
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good 
manufacturing practice (CGMP)); (2) section 502(f)(1) (21 U.S.C. 
352(f)(1)) (concerning the labeling of drugs with adequate directions 
for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval 
of human drug products under new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs)).
    One of the conditions that must be satisfied to qualify for the 
exemptions under section 503A of the FD&C Act is that a bulk drug 
substance (active pharmaceutical ingredient) used in a compounded drug 
product must meet one of the following criteria: (1) Complies with the 
standards of an applicable United States Pharmacopoeia (USP) or 
National Formulary monograph, if a monograph exists, and the USP 
chapter on pharmacy compounding; (2) if an applicable monograph does 
not exist, is a component of a drug approved by the Secretary of Health 
and Human Services (the Secretary); or (3) if such a monograph does not 
exist and the drug substance is not a component of a drug approved by 
the Secretary, appears on a list (the ``section 503A bulk drug 
substances list'') developed by the Secretary through regulations 
issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on 
the section 503A bulk drug substances list.
    Agenda: The committee intends to discuss six bulk drug substances 
nominated for inclusion on the section 503A bulk drug substances list. 
FDA intends to discuss the following nominated bulk drug substances: 
Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea 
tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The 
nominators of these substances will be invited to make a short 
presentation supporting the nomination. During the afternoon session, 
the committee will receive updates on certain issues to follow up on 
discussions from previous meetings, including the option for obtaining 
access to investigational new drugs under expanded access.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before June 
15, 2016. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 9:40 a.m., 10:35 a.m. and 10:45 a.m., 11:40 
a.m. and 11:50 a.m., 2:15 p.m. and 2:25 p.m., 3:20 p.m. and 3:30 p.m., 
and 4:40 p.m. and 4:50 p.m. Those individuals interested in making 
formal oral presentations should notify Cindy Hong and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before June 10, 2016. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by June 13, 
2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Cindy Hong at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13169 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P

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