81 FR 35782 - Pharmacy Compounding Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 107 (June 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 107 (June 3, 2016)
| Page Range | 35782-35783 | |
| FR Document | 2016-13169 |
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)] [Notices] [Pages 35782-35783] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13169] ----------------------------------------------------------------------- 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: http://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: [email protected], 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 http://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 http://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 http://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
![35782 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
‘‘Search’’ box and follow the prompts harmonization of technical it satisfies the requirements of the
and/or go to the Division of Dockets requirements for the registration of applicable statutes and regulations.
Management, 5630 Fishers Lane, Rm. pharmaceutical products for human use
II. Electronic Access
1061, Rockville, MD 20852. among regulators around the world. The
Submit written requests for single six founding members of the ICH are the Persons with access to the Internet
copies of this draft guidance to the European Commission; the European may obtain the document at http://
Division of Drug Information, Center for Federation of Pharmaceutical Industries www.regulations.gov, http://
Drug Evaluation and Research (CDER), Associations; the Japanese Ministry of www.fda.gov/Drugs/Guidance
Food and Drug Administration, 10001 Health, Labour, and Welfare; the ComplianceRegulatoryInformation/
New Hampshire Ave., Hillandale Japanese Pharmaceutical Manufacturers Guidances/default.htm, or http://
Building, 4th Floor, Silver Spring, MD Association; CDER and CDRH, FDA; and www.fda.gov/MedicalDevices/device
20993–0002, or the Office of the Pharmaceutical Research and regulationandguidance/guidance
Communication, and Education, Manufacturers of America. The standing documents/default.htm.
(CDRH), Division of Industry and members of the ICH Association include Dated: May 31, 2016.
Consumer Education, Center for Devices Health Canada and Swissmedic. Any Leslie Kux,
and Radiological Health, Food and Drug party eligible as a member in Associate Commissioner for Policy.
Administration, 10903 New Hampshire accordance with the ICH Articles of
[FR Doc. 2016–13168 Filed 6–2–16; 8:45 am]
Ave., Bldg. 66, Rm. 4621, Silver Spring, Association can apply for membership
BILLING CODE 4164–01–P
MD 20993–0002. Send one self- in writing to the ICH Secretariat. The
addressed adhesive label to assist that ICH Secretariat, which coordinates the
office in processing your requests. See preparation of documentation, operates
DEPARTMENT OF HEALTH AND
the SUPPLEMENTARY INFORMATION section as an international nonprofit
HUMAN SERVICES
for electronic access to the guidance organization and is funded by the
document. members of the ICH Association. Food and Drug Administration
The ICH Assembly includes
FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2016–N–0001]
representatives from each of the ICH
Regarding the draft guidance: Christian members, as well as observers from the
Grimstein, Center for Drug Evaluation World Health Organization and Drug Pharmacy Compounding Advisory
and Research (CDER), Food and Drug Regulatory Authorities and Regional Committee; Notice of Meeting
Administration, 10903 New Hampshire Harmonization Initiatives from around
Ave., Bldg. 51, Rm. 3116, Silver Spring, AGENCY: Food and Drug Administration,
the world. HHS.
MD 20993–0002, 301–796–5189; or In December 2015, the ICH Assembly
Eunice Lee, Center for Devices and ACTION: Notice.
endorsed the draft guidance entitled
Radiological Health (CDRH), Food and ‘‘E18 Genomic Sampling and SUMMARY: The Food and Drug
Drug Administration, 10903 New Management of Genomic Data’’ and Administration (FDA) announces a
Hampshire Ave., Bldg. 66, Rm. 5546, agreed that the guidance should be forthcoming public advisory committee
Silver Spring, MD 20993–0002, 301– made available for public comment. The meeting of the Pharmacy Compounding
796–4808. draft guidance is the product of the Advisory Committee. The general
Regarding the ICH: Amanda Roache, Efficacy Expert Working Group of the function of the committee is to provide
Center for Drug Evaluation and Research ICH. Comments about this draft will be advice on scientific, technical, and
(CDER), Food and Drug Administration, considered by FDA and the Efficacy medical issues concerning drug
10903 New Hampshire Ave., Bldg. 51, Expert Working Group. compounding under sections 503A and
Rm. 1128, Silver Spring, MD 20993– The draft guidance provides guidance 503B of the Federal Food, Drug, and
0002, 301–796–4548. on genomic sampling and management Cosmetic Act (FD&C Act), and, as
SUPPLEMENTARY INFORMATION: of genomic data from interventional and required, any other product for which
non-interventional clinical studies. The FDA has regulatory responsibility, and
I. Background draft guidance addresses use of genomic make appropriate recommendations to
In recent years, many important samples and data irrespective of the the Agency. The meeting will be open
initiatives have been undertaken by timing of analyses and both pre- to the public.
regulatory authorities and industry specified and non-pre-specified use.
DATES: The meeting will be held on June
associations to promote international The focus is on the general principles of
23, 2016, from 8:30 a.m. to 5 p.m.
harmonization of regulatory collecting, processing, transporting,
requirements. FDA has participated in ADDRESSES: FDA White Oak Campus,
storing and disposing of genomic
many meetings designed to enhance samples or data, within the scope of an 10903 New Hampshire Ave., Bldg. 31
harmonization and is committed to informed consent. The technical aspects Conference Center, the Great Room (Rm.
seeking scientifically based harmonized of genomic sampling and research are 1503), Silver Spring, MD 20993–0002.
technical procedures for pharmaceutical also discussed when appropriate, Answers to commonly asked questions
development. One of the goals of recognizing the rapidly evolving including information regarding special
harmonization is to identify and then technological advances in these areas. accommodations due to a disability,
reduce differences in technical This draft guidance is being issued visitor parking, and transportation may
requirements for drug development consistent with FDA’s good guidance be accessed at: http://www.fda.gov/
among regulatory agencies. practices regulation (21 CFR 10.115). AdvisoryCommittees/
mstockstill on DSK3G9T082PROD with NOTICES
ICH was organized to provide an The draft guidance, when finalized, will AboutAdvisoryCommittees/
opportunity for harmonization represent the current thinking of FDA ucm408555.htm.
initiatives to be developed with input on ‘‘E18 Genomic Sampling and FOR FURTHER INFORMATION CONTACT:
from both regulatory and industry Management of Genomic Data.’’ It does Cindy Hong, Center for Drug Evaluation
representatives. FDA also seeks input not establish any rights for any person and Research, Food and Drug
from consumer representatives and and is not binding on FDA or the public. Administration, 10903 New Hampshire
others. ICH is concerned with You can use an alternative approach if Ave., Bldg. 31, Rm. 2417, Silver Spring,
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![Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35783
MD 20993–0002, 301–796–9001, FAX: 503A bulk drug substances list. FDA FDA welcomes the attendance of the
301–847–8533, email: PCAC@ intends to discuss the following public at its advisory committee
fda.hhs.gov, or FDA Advisory nominated bulk drug substances: meetings and will make every effort to
Committee Information Line, 1–800– Chrysin, cesium chloride, sodium accommodate persons with disabilities.
741–8138 (301–443–0572 in the dichloroacetate, pyruvic acid, tea tree If you require accommodations due to a
Washington, DC area). A notice in the oil, and 2,3-Dimercapto-1- disability, please contact Cindy Hong at
Federal Register about last minute propanesulfonic acid (DMPS). The least 7 days in advance of the meeting.
modifications that impact a previously nominators of these substances will be FDA is committed to the orderly
announced advisory committee meeting invited to make a short presentation conduct of its advisory committee
cannot always be published quickly supporting the nomination. During the meetings. Please visit our Web site at
enough to provide timely notice. afternoon session, the committee will http://www.fda.gov/
Therefore, you should always check the receive updates on certain issues to AdvisoryCommittees/
Agency’s Web site at http:// follow up on discussions from previous AboutAdvisoryCommittees/
www.fda.gov/AdvisoryCommittees/ meetings, including the option for ucm111462.htm for procedures on
default.htm and scroll down to the obtaining access to investigational new public conduct during advisory
appropriate advisory committee meeting drugs under expanded access. committee meetings.
link, or call the advisory committee FDA intends to make background Notice of this meeting is given under
information line to learn about possible material available to the public no later the Federal Advisory Committee Act (5
modifications before coming to the than 2 business days before the meeting. U.S.C. app. 2).
meeting. If FDA is unable to post the background Dated: May 31, 2016.
Background: Section 503A of the material on its Web site prior to the Leslie Kux,
FD&C Act (21 U.S.C. 353a) describes the meeting, the background material will Associate Commissioner for Policy.
conditions that must be satisfied for be made publicly available at the
human drug products compounded by a [FR Doc. 2016–13169 Filed 6–2–16; 8:45 am]
location of the advisory committee BILLING CODE 4164–01–P
licensed pharmacist or licensed meeting, and the background material
physician to be exempt from the will be posted on FDA’s Web site after
following three sections of the FD&C the meeting. Background material is
Act: (1) Section 501(a)(2)(B) (21 U.S.C. DEPARTMENT OF HEALTH AND
available at http://www.fda.gov/ HUMAN SERVICES
351(a)(2)(B)) (concerning current good AdvisoryCommittees/Calendar/
manufacturing practice (CGMP)); (2) default.htm. Scroll down to the Health Resources and Services
section 502(f)(1) (21 U.S.C. 352(f)(1)) appropriate advisory committee meeting Administration
(concerning the labeling of drugs with link.
adequate directions for use); and (3) National Vaccine Injury Compensation
Procedure: Interested persons may
section 505 (21 U.S.C. 355) (concerning Program; List of Petitions Received
present data, information, or views,
the approval of human drug products
under new drug applications (NDAs) or orally or in writing, on issues pending AGENCY: Health Resources and Services
abbreviated new drug applications before the committee. Written Administration, HHS.
(ANDAs)). submissions may be made to the contact ACTION: Notice.
One of the conditions that must be person on or before June 15, 2016. Oral
satisfied to qualify for the exemptions presentations from the public will be SUMMARY: The Health Resources and
under section 503A of the FD&C Act is scheduled between approximately 9:30 Services Administration (HRSA) is
that a bulk drug substance (active a.m. and 9:40 a.m., 10:35 a.m. and 10:45 publishing this notice of petitions
pharmaceutical ingredient) used in a a.m., 11:40 a.m. and 11:50 a.m., 2:15 received under the National Vaccine
compounded drug product must meet p.m. and 2:25 p.m., 3:20 p.m. and 3:30 Injury Compensation Program (the
one of the following criteria: (1) p.m., and 4:40 p.m. and 4:50 p.m. Those Program), as required by Section
Complies with the standards of an individuals interested in making formal 2112(b)(2) of the Public Health Service
applicable United States Pharmacopoeia oral presentations should notify Cindy (PHS) Act, as amended. While the
(USP) or National Formulary Hong and submit a brief statement of the Secretary of Health and Human Services
monograph, if a monograph exists, and general nature of the evidence or (HHS) is named as the respondent in all
the USP chapter on pharmacy arguments they wish to present, the proceedings brought by the filing of
compounding; (2) if an applicable names and addresses of proposed petitions for compensation under the
monograph does not exist, is a participants, and an indication of the Program, the United States Court of
component of a drug approved by the approximate time requested to make Federal Claims is charged by statute
Secretary of Health and Human Services their presentation on or before June 10, with responsibility for considering and
(the Secretary); or (3) if such a 2016. Time allotted for each acting upon the petitions.
monograph does not exist and the drug presentation may be limited. If the SUPPLEMENTARY INFORMATION: The
substance is not a component of a drug number of registrants requesting to Program provides a system of no-fault
approved by the Secretary, appears on a speak is greater than can be reasonably compensation for certain individuals
list (the ‘‘section 503A bulk drug accommodated during the scheduled who have been injured by specified
substances list’’) developed by the open public hearing session, FDA may childhood vaccines. Subtitle 2 of Title
Secretary through regulations issued by conduct a lottery to determine the XXI of the PHS Act, 42 U.S.C. 300aa–
speakers for the scheduled open public 10 et seq. provides that those seeking
mstockstill on DSK3G9T082PROD with NOTICES
the Secretary (see section
503A(b)(1)(A)(i) of the FD&C Act). hearing session. The contact person will compensation are to file a petition with
FDA will discuss with the committee notify interested persons regarding their the U.S. Court of Federal Claims and to
drugs proposed for inclusion on the request to speak by June 13, 2016. serve a copy of the petition on the
section 503A bulk drug substances list. Persons attending FDA’s advisory Secretary of HHS, who is named as the
Agenda: The committee intends to committee meetings are advised that the respondent in each proceeding. The
discuss six bulk drug substances Agency is not responsible for providing Secretary has delegated this
nominated for inclusion on the section access to electrical outlets. responsibility under the Program to
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Document Created: 2018-02-08 07:30:00
Document Modified: 2018-02-08 07:30:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The meeting will be held on June 23, 2016, from 8:30 a.m. to 5 p.m. | |
| Contact | Cindy Hong, 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], 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 http://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. | |
| FR Citation | 81 FR 35782 |
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