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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
available at https www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee meeting link.
Procedure: On November 4, 2021, the meeting is open to the public, from 9:30
a.m. to 11:30 a.m. for Topic I; 12:50 p.m.
to 2:10 p.m. for Topic II; and 3:10 p.m.
to 4:30 p.m. for Topic III. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be submitted to the contact person on or before October 28, 2021. Oral presentations from the public will be scheduled between approximately 11:10 a.m. and 11:30 a.m.
for Topic I; 1:50 p.m. and 2:10 p.m. for Topic II; and 4:10 p.m. and 4:30 p.m. for Topic III. 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 20, 2021. 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 21, 2021.
Closed Committee Deliberations: On November 4, 2021, from 11:30 a.m. to 12:20 p.m. for Topic I; 2:10 p.m. to 3
p.m. for Topic II; and 4:30 p.m. to 5:20
p.m. for Topic III, the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy 5 U.S.C. 552bc6. The recommendations of the advisory
committee regarding the progress of the individual investigators research programs along with other information, will be discussed during this session.
We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
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 Christina Vert BPAC@fda.hhs.gov 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/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings 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 3, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119686 Filed 91021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0104

PolyMedica Industries Inc., et al.;
Withdrawal of Approval of Three New Drug Applications AGENCY:

Food and Drug Administration,
HHS.

ACTION:

Notice.

The Food and Drug Administration FDA is withdrawing approval of three new drug applications NDAs from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.

SUMMARY:

Approval is withdrawn as of September 13, 2021.

DATES:

FOR FURTHER INFORMATION CONTACT:

Kimberly S. Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 209930002, 301
7963137, Kimberly.Lehrfeld@
fda.hhs.gov.
The holder of an approved application to market a new drug for human use is required to submit annual reports to FDA concerning its approved application in accordance with 314.81
21 CFR 314.81.
In the Federal Register of March 3, 2021 86 FR 12474, FDA published a notice offering an opportunity for a hearing NOOH on a proposal to withdraw approval of those NDAs because the holders of those NDAs had repeatedly failed to submit the required annual reports for those NDAs. The holders of the NDAs identified in table 1 did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by 314.200 21 CFR 314.200 constitutes an election by those holders of the NDAs not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their NDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the three applications listed in table 1.

SUPPLEMENTARY INFORMATION:

TABLE 1APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.

Drug
NDA Holder
NDA 016401

Neopap acetaminophen Suppositories, 120 milligrams mg.
Achromycin tetracycline hydrochloride HCl Ophthalmic Ointment, 10 mg/gram.
Achromycin tetracycline HCl Ophthalmic Suspension, 1%

PolyMedica Industries Inc., 2 Constitution Way, Woburn, MA 01801.
Storz Ophthalmics Inc. subsidiary of American Cyanamid Co., 401 North Middletown Rd., Pearl River, NY 10965.
Do.

NDA 050266

lotter on DSK11XQN23PROD with NOTICES1

NDA 050268

FDA finds that the holders of the NDAs listed in table 1 have repeatedly failed to submit reports required by 314.81. In addition, under 314.200, FDA finds that the holders of the NDAs
VerDate Sep<11>2014

17:39 Sep 10, 2021

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have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the NDAs listed in table 1 and all amendments and
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supplements thereto is hereby withdrawn as of September 13, 2021.

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