83 FR 49101 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49101-49102 | |
| FR Document | 2018-21137 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49101-49102] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21137] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3424] Vaccines and Related Biological 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 Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on November 8, 2018, from 11 a.m. to 2:45 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/vrbpac1118/. 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, serina.hunter-thomas@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 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. SUPPLEMENTARY INFORMATION: Agenda: On November 8, 2018, the Center for Biologics Evaluation and Research's (CBER) VRBPAC committee will meet in open session to hear an overview of the research program in the Laboratory of DNA Viruses (LDV), Division of Viral Products (DVP), Office of Vaccines Research and Review (OVRR), CBER, FDA. 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 8, 2018, from 11 a.m. to 1:50 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 [[Page 49102]] person on or before November 1, 2018. Oral presentations from the public will be scheduled between approximately 12:45 p.m. to 1:45 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 24, 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 25, 2018. Closed Committee Deliberations: On November 8, 2018, from 1:50 p.m. to 2:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the investigator's research will, along with other information, be used in making personnel and staffing decisions regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21137 Filed 9-27-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49101
occur again. Yet, again, McCoy has not As a result of the foregoing findings, Answers to commonly asked questions
provided any specific allegations or McCoy is debarred for 4 years from including information regarding special
evidence to challenge ORA’s providing services in any capacity to a accommodations due to a disability,
determination that this consideration person with an approved or pending visitor parking, and transportation may
does not apply to him. FDA need only drug product application under section be accessed at: https://www.fda.gov/
address the considerations in section 505, 512, or 802 of the FD&C Act (21 AdvisoryCommittees/AboutAdvisory
306(c)(3) of the FD&C Act ‘‘where U.S.C. 355, 360b, or 382), or under Committees/ucm408555.htm.
applicable.’’ The considerations in section 351 of the Public Health Service For those unable to attend in person,
section 306(c)(3) of the FD&C Act are Act (42 U.S.C. 262), effective (see DATES) the meeting will also be webcast and
not only for individuals but also for (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) will be available at the following link:
corporations, partnerships, and and 21 U.S.C. 321(dd)). Any person https://collaboration.fda.gov/
associations subject to permissive with an approved or pending drug vrbpac1118/.
debarment. The consideration at issue product application, who knowingly FOR FURTHER INFORMATION CONTACT:
does not typically apply to individuals uses the services of McCoy, in any Serina Hunter-Thomas, Center for
because individuals are incapable of capacity during his period of Biologics Evaluation and Research,
changes in ownership or management debarment, will be subject to civil Food and Drug Administration, 10903
and could only alter the current money penalties (section 307(a)(6) of the New Hampshire Ave., Bldg. 71, Rm.
operations of a business enterprise in FD&C Act (21 U.S.C. 335b(a)(6))). If 6338, Silver Spring, MD 20993–0002,
which they are currently engaged. Even McCoy, during his period of debarment, 240–402–5771, serina.hunter-thomas@
assuming arguendo that an individual provides services in any capacity to a fda.hhs.gov or FDA Advisory Committee
could point to changes in his or her person with an approved or pending Information Line, 1–800–741–8138
current business practices as an drug product application, he will be (301–443–0572 in the Washington, DC
applicable consideration under section subject to civil money penalties (section area). A notice in the Federal Register
306(c)(3) of the FD&C Act, McCoy’s 307(a)(7) of the FD&C Act). In addition, about last minute modifications that
unsubstantiated contention that there FDA will not accept or review any impact a previously announced
are disputed issues of fact with respect abbreviated new drug applications advisory committee meeting cannot
to that consideration fails to create a submitted by or with the assistance of always be published quickly enough to
genuine and substantial issue of fact McCoy during his period of debarment provide timely notice. Therefore, you
that warrants a hearing. (section 306(c)(1)(B) of the FD&C Act). should always check the Agency’s
Based on the factual findings in the
Dated: September 25, 2018. website at https://www.fda.gov/
proposal to debar and on the record, OSI
George M. Warren, AdvisoryCommittees/default.htm and
finds that a 4-year debarment is
Director, Office of Scientific Integrity. scroll down to the appropriate advisory
appropriate. Although McCoy has no
committee meeting link, or call the
previous criminal convictions related to [FR Doc. 2018–21211 Filed 9–27–18; 8:45 am]
advisory committee information line to
matters within the jurisdiction of FDA, BILLING CODE 4164–01–P
learn about possible modifications
this sole positive factor does not
before coming to the meeting.
counterbalance the nature and
seriousness of his offense and lack of DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
voluntary steps taken to mitigate the HUMAN SERVICES Agenda: On November 8, 2018, the
effect on the public. As noted in the Center for Biologics Evaluation and
proposal to debar, McCoy’s actions Food and Drug Administration Research’s (CBER) VRBPAC committee
occurred on a repeated basis, and ‘‘[his] will meet in open session to hear an
[Docket No. FDA–2018–N–3424]
conduct created a risk of injury to [his] overview of the research program in the
patients . . ., undermined the Agency’s Vaccines and Related Biological Laboratory of DNA Viruses (LDV),
oversight of an approved drug product, Products Advisory Committee; Notice Division of Viral Products (DVP), Office
and seriously undermined the integrity of Meeting of Vaccines Research and Review
of the Agency’s regulation of drug (OVRR), CBER, FDA. FDA intends to
products.’’ AGENCY: Food and Drug Administration, make background material available to
HHS. the public no later than 2 business days
III. Findings and Order ACTION: Notice. before the meeting. If FDA is unable to
Therefore, the Director of OSI, under post the background material on its
section 306(b)(2)(B)(i)(I) of the FD&C SUMMARY: The Food and Drug website prior to the meeting, the
Act and under authority delegated to Administration (FDA) announces a background material will be made
him by the Commissioner of Food and forthcoming public advisory committee publicly available at the location of the
Drugs, finds that: (1) McCoy has been meeting of the Vaccines and Related advisory committee meeting, and the
convicted of a misdemeanor under Biological Products Advisory background material will be posted on
Federal law for conduct relating to the Committee (VRBPAC). The general FDA’s website after the meeting.
development or approval, including the function of the committee is to provide Background material is available at
process for development or approval, of advice and recommendations to the https://www.fda.gov/Advisory
a drug product or otherwise relating to Agency on FDA’s regulatory issues. At Committees/Calendar/default.htm.
the regulation of a drug product under least one portion of the meeting will be Scroll down to the appropriate advisory
the FD&C Act and (2) the conduct which closed to the public. committee meeting link.
amozie on DSK3GDR082PROD with NOTICES1
served as the basis for the conviction DATES: The meeting will be held on Procedure: On November 8, 2018,
undermines the process for the November 8, 2018, from 11 a.m. to 2:45 from 11 a.m. to 1:50 p.m., the meeting
regulation of drugs. FDA has considered p.m. is open to the public. Interested persons
the applicable factors listed in section ADDRESSES: FDA White Oak Campus, may present data, information, or views,
306(c)(3) of the FD&C Act and 10903 New Hampshire Ave., Bldg. 31 orally or in writing, on issues pending
determined that a debarment of 4 years Conference Center, the Great Room (Rm. before the committee. Written
is appropriate. 1503), Silver Spring, MD 20993–0002. submissions may be made to the contact
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49290/page/1.svg)
![49102 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
person on or before November 1, 2018. Persons attending FDA’s advisory ACTION: Notice.
Oral presentations from the public will committee meetings are advised that the
be scheduled between approximately Agency is not responsible for providing SUMMARY: The Food and Drug
12:45 p.m. to 1:45 p.m. Those access to electrical outlets. Administration (FDA or Agency) is
individuals interested in making formal FDA welcomes the attendance of the withdrawing approval of 24 abbreviated
oral presentations should notify the public at its advisory committee new drug applications (ANDAs) from
contact person and submit a brief meetings and will make every effort to multiple applicants. The applicants
statement of the general nature of the accommodate persons with disabilities. notified the Agency in writing that the
evidence or arguments they wish to If you require accommodations due to a drug products were no longer marketed
present, the names and addresses of disability, please contact Serina Hunter- and requested that the approval of the
proposed participants, and an Thomas at least 7 days in advance of the
indication of the approximate time applications be withdrawn.
meeting.
requested to make their presentation on FDA is committed to the orderly DATES:Approval is withdrawn as of
or before October 24, 2018. Time conduct of its advisory committee October 29, 2018.
allotted for each presentation may be meetings. Please visit our website at:
limited. If the number of registrants FOR FURTHER INFORMATION CONTACT:
https://www.fda.gov/
requesting to speak is greater than can AdvisoryCommittees/AboutAdvisory Trang Tran, Center for Drug Evaluation
be reasonably accommodated during the Committees/ucm111462.htm for and Research, Food and Drug
scheduled open public hearing session, procedures on public conduct during Administration, 10903 New Hampshire
FDA may conduct a lottery to determine advisory committee meetings. Ave., Bldg. 75, Rm. 1671, Silver Spring,
the speakers for the scheduled open Notice of this meeting is given under MD 20993–0002, 240–402–7945,
public hearing session. The contact the Federal Advisory Committee Act (5 Trang.Tran@fda.hhs.gov.
person will notify interested persons U.S.C. app. 2). SUPPLEMENTARY INFORMATION: The
regarding their request to speak by
October 25, 2018.
Dated: September 24, 2018. applicants listed in the table have
Closed Committee Deliberations: On Leslie Kux, informed FDA that these drug products
November 8, 2018, from 1:50 p.m. to Associate Commissioner for Policy. are no longer marketed and have
2:45 p.m., the meeting will be closed to [FR Doc. 2018–21137 Filed 9–27–18; 8:45 am] requested that FDA withdraw approval
permit discussion where disclosure BILLING CODE 4164–01–P of the applications under the process
would constitute a clearly unwarranted described in § 314.150(c) (21 CFR
invasion of personal privacy (5 U.S.C. 314.150(c)). The applicants have also,
552b(c)(6)). The recommendations of the DEPARTMENT OF HEALTH AND by their requests, waived their
advisory committee regarding the HUMAN SERVICES opportunity for a hearing. Withdrawal
progress of the investigator’s research of approval of an application or
will, along with other information, be Food and Drug Administration abbreviated application under
used in making personnel and staffing § 314.150(c) is without prejudice to
[Docket No. FDA–2018–N–3569]
decisions regarding individual refiling.
scientists. GlaxoSmithKline, LLC, et al.;
We believe that public discussion of Withdrawal of Approval of 24
these recommendations on individual Abbreviated New Drug Applications
scientists would constitute an
unwarranted invasion of personal AGENCY: Food and Drug Administration,
privacy. HHS.
Application No. Drug Applicant
ANDA 061336 .... Bactocill (oxacillin sodium) Capsules, Equivalent to (EQ) 250 GlaxoSmithKline, LLC, Five Moore Dr., P.O. Box 13398, Re-
milligrams (mg) base and EQ 500 mg base. search Triangle Park, NC 27709.
ANDA 061773 .... Kefzol (cefazolin) for Injection USP, EQ 250 mg base/vial, ACS Dobfar S.p.A., c/o Interchem Corp., 120 Rte. 17 North,
EQ 500 mg base/vial, EQ 1 gram (g) base/vial, EQ 10 g Paramus, NJ 07652.
base/vial, and EQ 20 g base/vial.
ANDA 062615 .... Nystatin Vaginal Inserts USP, 100,000 units ........................... Odyssey Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 063304 .... Clindamycin Phosphate Topical Solution USP, EQ 1% base Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
ANDA 065001 .... Cefuroxime for Injection USP, EQ 750mg base/vial and EQ Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
1.5 g base/vial. IL 60047.
ANDA 065002 .... Cefuroxime for Injection USP, EQ 7.5 g base/vial (Pharmacy Do.
Bulk Package).
ANDA 070736 .... Ibuprofen Tablets USP, 300 mg, 400 mg, and 600 mg .......... Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East
Windsor, NJ 08520.
ANDA 071202 .... Sensorcaine—MPF Spinal (bupivacaine hydrochloride (HCl)) Fresenius Kabi USA, LLC.
in Dextrose Injection 8.25% USP, 0.75%.
amozie on DSK3GDR082PROD with NOTICES1
ANDA 071846 .... Nitroglycerin in Dextrose 5% Injection, 10 mg/100 milliliter Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
(mL). 60045.
ANDA 071847 .... Nitroglycerin in Dextrose 5% Injection, 20 mg/100 mL ........... Do.
ANDA 071848 .... Nitroglycerin in Dextrose 5% Injection, 40 mg/100 mL ........... Do.
ANDA 072629 .... Albuterol Tablets USP, EQ 2 mg base .................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 074991 .... Loperamide HCl Oral Solution, 1 mg/5 mL ............................. Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49290/page/2.svg)
Document Created: 2018-09-28 01:23:23
Document Modified: 2018-09-28 01:23:23
| 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 8, 2018, from 11 a.m. to 2:45 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 49101 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR