83 FR 48634 - Allergenic Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48634-48635 | |
| FR Document | 2018-20905 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48634-48635] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20905] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3305] Allergenic Products 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 Allergenic Products Advisory Committee (APAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on November 7, 2018, from 9 a.m. to 4 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 those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac2018/. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, [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 website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee [[Page 48635]] information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On November 7, 2018, the Center for Biologics Evaluation and Research's APAC will meet in open session to discuss the use of challenge studies in the clinical development of allergenic products for the diagnosis and treatment of allergy due to aeroallergens. 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 website 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 website 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: On November 7, 2018, from 9 a.m. to 4 p.m., the meeting is open to the public. 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 October 31, 2018. Oral presentations from the public will be scheduled between approximately 12:30 p.m. to 1:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person 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 October 23, 2018. 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 October 24, 2018. 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 Serina Hunter-Thomas at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20905 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![48634 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
0002. Send one self-addressed adhesive document concerning compounding and Dated: September 20, 2018.
label to assist that office in processing repackaging of radiopharmaceuticals by Leslie Kux,
your requests. See the SUPPLEMENTARY outsourcing facilities entitled Associate Commissioner for Policy.
INFORMATION section for electronic ‘‘Compounding and Repackaging of [FR Doc. 2018–20902 Filed 9–25–18; 8:45 am]
access to the guidance document. Radiopharmaceuticals by Outsourcing BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Sara Facilities.’’
Rothman, Center for Drug Evaluation In the Federal Register of December
and Research, Food and Drug 29, 2016 (81 FR 96011), FDA issued a DEPARTMENT OF HEALTH AND
Administration, 10903 New Hampshire notice announcing the availability of the HUMAN SERVICES
Ave., Bldg. 51, Silver Spring, MD 301– draft version of this guidance. The
796–3110. comment period on the draft guidance Food and Drug Administration
SUPPLEMENTARY INFORMATION: ended on February 27, 2017. FDA [Docket No. FDA–2018–N–3305]
received comments on the draft
I. Background Allergenic Products Advisory
guidance. In response to received
FDA is announcing the availability of comments or on its own initiative, FDA Committee; Notice of Meeting
a guidance for industry entitled made several changes that are reflected
‘‘Compounding and Repackaging of AGENCY: Food and Drug Administration,
in this final guidance. For example, in HHS.
Radiopharmaceuticals by State-Licensed response to requests in comments for
Nuclear Pharmacies, Federal Facilities, clarification regarding the beyond-use- ACTION: Notice.
and Certain Other Entities.’’ Under date, FDA added a recommendation that
current law, radiopharmaceuticals that SUMMARY: The Food and Drug
sterile radiopharmaceuticals should be Administration (FDA) announces a
are compounded by entities that are not compounded in compliance with USP
registered with FDA as outsourcing forthcoming public advisory committee
Chapter <797>. In addition, to address meeting of the Allergenic Products
facilities, and radiopharmaceuticals that questions raised in comments, FDA
are repackaged, are subject to all Advisory Committee (APAC). The
clarified the applicability of this general function of the committee is to
applicable provisions of the FD&C Act guidance to various settings in which
related to the production of drugs. provide advice and recommendations to
radiopharmaceuticals are administered, the Agency on FDA’s regulatory issues.
Because Congress explicitly excluded such as nuclear medicine departments
radiopharmaceuticals from section 503A The meeting will be open to the public.
and imaging centers, by clarifying that
of the FD&C Act (21 U.S.C. 353a) (see DATES: The meeting will be held on
the policies in the guidance apply to
section 503A(d)(2)),1 compounded November 7, 2018, from 9 a.m. to 4 p.m.
facilities that are not outsourcing
radiopharmaceuticals are not eligible for facilities and that hold a RAM license ADDRESSES: FDA White Oak Campus,
the exemptions under section 503A for medical use issued by the NRC or by 10903 New Hampshire Ave., Bldg. 31
from section 505 (21 U.S.C. 355) an Agreement State. Conference Center, the Great Room (Rm.
(concerning new drug approval 1503), Silver Spring, MD 20993–0002.
requirements), section 502(f)(1) (21 This guidance is being issued Answers to commonly asked questions
U.S.C. 352(f)(1)) (concerning labeling consistent with FDA’s good guidance including information regarding special
with adequate directions for use), and practices regulation (21 CFR 10.115). accommodations due to a disability,
section 501(a)(2)(B) (21 U.S.C. The guidance represents the current visitor parking, and transportation may
351(a)(2)(B)) (concerning current good thinking of FDA on ‘‘Compounding and be accessed at: https://www.fda.gov/
manufacturing practice requirements). Repackaging of Radiopharmaceuticals AdvisoryCommittees/AboutAdvisory
In addition, the FD&C Act does not by State-Licensed Nuclear Pharmacies, Committees/ucm408555.htm. For those
provide an exemption for repackaged Federal Facilities, and Certain Other unable to attend in person, the meeting
radiopharmaceuticals. Entities.’’ It does not establish any rights will also be webcast and will be
FDA is issuing this guidance to for any person and is not binding on available at the following link: https://
describe the conditions under which the FDA or the public. You can use an collaboration.fda.gov/vrbpac2018/.
Agency generally does not intend to alternative approach if it satisfies the
FOR FURTHER INFORMATION CONTACT:
take action for violations of sections requirements of the applicable statutes
and regulations. This guidance is not Serina Hunter-Thomas, Center for
505, 502(f)(1), and 501(a)(2)(B) of the Biologics Evaluation and Research,
FD&C Act when a State-licensed nuclear subject to Executive Order 12866.
Food and Drug Administration, 10903
pharmacy, Federal facility, or other II. Paperwork Reduction Act of 1995 New Hampshire Ave., Bldg. 71, Rm.
facility that is not an outsourcing 6338, Silver Spring, MD 20993–0002,
facility and that holds a RAM license for This guidance contains collections of 240–402–5771, serina.hunter-thomas@
medical use issued by the NRC or by an information that are subject to review by fda.hhs.gov, or FDA Advisory
Agreement State compounds or the Office of Management and Budget Committee Information Line, 1–800–
repackages radiopharmaceuticals for under the Paperwork Reduction Act of 741–8138 (301–443–0572 in the
human use. 1995 (44 U.S.C. 3501–3520). The Washington, DC area). A notice in the
Elsewhere in this issue of the Federal collections of information have been Federal Register about last minute
Register, FDA has announced the approved under OMB control number modifications that impact a previously
availability of a separate guidance 0910–0858. announced advisory committee meeting
III. Electronic Access cannot always be published quickly
daltland on DSKBBV9HB2PROD with NOTICES
1 Section 503A of the FD&C Act describes the
conditions that must be met for drug products
enough to provide timely notice.
compounded by a licensed pharmacist in a State- Persons with access to the internet Therefore, you should always check the
licensed pharmacy or Federal facility, or by a may obtain the guidance at either Agency’s website at https://
licensed physician, to qualify for exemptions from https://www.fda.gov/Drugs/Guidance www.fda.gov/AdvisoryCommittees/
sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C
Act. Section 503A(d)(2) of the FD&C Act states that
ComplianceRegulatoryInformation/ default.htm and scroll down to the
‘‘this section shall not apply to . . . Guidances/default.htm or https:// appropriate advisory committee meeting
radiopharmaceuticals.’’ www.regulations.gov. link, or call the advisory committee
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![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48635
information line to learn about possible or before October 23, 2018. Time DEPARTMENT OF HEALTH AND
modifications before coming to the allotted for each presentation may be HUMAN SERVICES
meeting. limited. If the number of registrants
requesting to speak is greater than can Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Agenda: On November 7, 2018, the be reasonably accommodated during the [Docket No. FDA–2018–N–3463]
Center for Biologics Evaluation and scheduled open public hearing session,
Research’s APAC will meet in open FDA may conduct a lottery to determine Aurolife Pharma, LLC, et al.;
session to discuss the use of challenge the speakers for the scheduled open Withdrawal of Approval of Seven
studies in the clinical development of public hearing session. The contact Abbreviated New Drug Applications
allergenic products for the diagnosis person will notify interested persons
AGENCY: Food and Drug Administration,
and treatment of allergy due to regarding their request to speak by
HHS.
aeroallergens. FDA intends to make October 24, 2018.
ACTION: Notice.
background material available to the Persons attending FDA’s advisory
public no later than 2 business days committee meetings are advised that the SUMMARY: The Food and Drug
before the meeting. If FDA is unable to Agency is not responsible for providing Administration (FDA or Agency) is
post the background material on its access to electrical outlets. withdrawing approval of seven
website prior to the meeting, the abbreviated new drug applications
background material will be made FDA welcomes the attendance of the
public at its advisory committee (ANDAs) from multiple applicants. The
publicly available at the location of the applicants notified the Agency in
advisory committee meeting, and the meetings and will make every effort to
writing that the drug products were no
background material will be posted on accommodate persons with disabilities.
longer marketed and requested that the
FDA’s website after the meeting. If you require accommodations due to a
approval of the applications be
Background material is available at disability, please contact Serina Hunter- withdrawn.
https://www.fda.gov/Advisory Thomas at least 7 days in advance of the
Committees/Calendar/default.htm. meeting. DATES: Approval is withdrawn as of
Scroll down to the appropriate advisory October 26, 2018.
FDA is committed to the orderly
committee meeting link. FOR FURTHER INFORMATION CONTACT:
conduct of its advisory committee
Procedure: On November 7, 2018, Trang Tran, Center for Drug Evaluation
meetings. Please visit our website at:
from 9 a.m. to 4 p.m., the meeting is and Research, Food and Drug
https://www.fda.gov/Advisory
open to the public. Interested persons Administration, 10903 New Hampshire
Committees/AboutAdvisoryCommittees/
may present data, information, or views, Ave., Bldg. 75, Rm. 1671, Silver Spring,
ucm111462.htm for procedures on MD 20993–0002, 240–402–7945,
orally or in writing, on issues pending public conduct during advisory
before the committee. Written Trang.Tran@fda.hhs.gov.
committee meetings.
submissions may be made to the contact SUPPLEMENTARY INFORMATION: The
person on or before October 31, 2018. Notice of this meeting is given under applicants listed in the table have
Oral presentations from the public will the Federal Advisory Committee Act (5 informed FDA that these drug products
be scheduled between approximately U.S.C. app. 2). are no longer marketed and have
12:30 p.m. to 1:30 p.m. Those Dated: September 20, 2018. requested that FDA withdraw approval
individuals interested in making formal Leslie Kux,
of the applications under the process
oral presentations should notify the described in § 314.150(c) (21 CFR
Associate Commissioner for Policy.
contact person and submit a brief 314.150(c)). The applicants have also,
statement of the general nature of the [FR Doc. 2018–20905 Filed 9–25–18; 8:45 am] by their requests, waived their
evidence or arguments they wish to BILLING CODE 4164–01–P opportunity for a hearing. Withdrawal
present, the names and addresses of of approval of an application or
proposed participants, and an abbreviated application under
indication of the approximate time § 314.150(c) is without prejudice to
requested to make their presentation on refiling.
Application No. Drug Applicant
ANDA 072112 ...................... Clorazepate Dipotassium Capsules, 3.75 milligrams Aurolife Pharma, LLC, 279 Princeton Hightstown Rd.,
(mg), 7.5 mg, and 15 mg. East Windsor, NJ 08520.
ANDA 074863 ...................... Clemastine Fumarate Syrup, Equivalent to (EQ) 0.5 mg Workhardt Bio AG, c/o Morton Grove Pharmaceuticals,
base/5 milliliters (mL). Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 080925 ...................... Isocaine 3% (mepivacaine hydrochloride (HCl)) Injec- Septodont, Inc., c/o Arent Fox, LLP, 1717 K St. NW,
tion USP, 3%. Washington, DC 20006.
ANDA 084048 ...................... Octocaine (lidocaine HCl and epinephrine) Injection Do.
USP, 2%; 0.01 mg/mL and 2%; 0.02 mg/mL.
ANDA 084697 ...................... Isocaine 2% (mepivacaine HCl and levonordefrin) Injec- Do.
tion USP, 2%; 0.05 mg/mL.
ANDA 086033 ...................... Isosorbide Dinitrate Sublingual Tablets USP, 2.5 mg .... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
daltland on DSKBBV9HB2PROD with NOTICES
19044.
ANDA 087504 ...................... Chloroquine Phosphate Tablets USP, EQ 150 mg base Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Therefore, approval of the amendments and supplements thereto, 2018. Introduction or delivery for
applications listed in the table, and all is hereby withdrawn as of October 26, introduction into interstate commerce of
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Document Created: 2018-09-26 00:47:51
Document Modified: 2018-09-26 00:47:51
| 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 November 7, 2018, from 9 a.m. to 4 p.m. | |
| Contact | Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, [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 website 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. | |
| FR Citation | 83 FR 48634 |
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