PolyMedica Industries Inc., et al.; Withdrawal of Approval of Three New Drug Applications, 50886-50887 [2021-19689]

Download as PDF 50886 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. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the individual investigator’s 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 301–796–4540. 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. 2021–19686 Filed 9–10–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0104] 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 20993–0002, 301– 796–3137, 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 1—APPROVED 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 Jkt 253001 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 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 supplements thereto is hereby withdrawn as of September 13, 2021. E:\FR\FM\13SEN1.SGM 13SEN1 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices Dated: September 3, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19689 Filed 9–10–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0881] Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care To Produce a Therapeutic Article Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA or Agency) is consolidating regulatory oversight responsibilities in the Center for Biologics Evaluation and Research (CBER) for certain devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by the Center for Devices and Radiological Health (CDRH) will be transferred to CBER for regulation. This action affects only center assignment. FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993, 301–796–8941, john.weiner@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: I. Consolidation in CBER of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care To Produce a Therapeutic Article FDA is consolidating regulatory oversight responsibilities in CBER for devices that process autologous human cells, tissues, and cellular and tissuebased products (HCT/Ps) at the point of care to produce a therapeutic article. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by CDRH will be transferred to CBER for regulation. This action affects only center assignment. VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 FDA has the authority to regulate devices as defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). Devices may be regulated by CDRH or CBER (see, e.g., Ref.1). In July 2007, the Agency published the final guidance ‘‘Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)’’ to assist sponsors in determining which center at FDA would have regulatory oversight for devices used at the point of care to process HCT/Ps (Ref. 2). Assignment of these devices is determined by whether the point-of-care device creates an HCT/P that is intended to mediate the intended therapeutic effect. Point-of-care devices that process autologous materials are assigned to CBER when the intended therapeutic effect is mediated by the biological output of the device. For example, a cell sorter that is used to isolate CD34+ cells from bone marrow for use in hematopoietic reconstitution is assigned to CBER for review and regulation because the cellular output of the device is intended to provide the intended therapeutic effect. Since the publication of the 2007 guidance, assignment of point-of-care devices intended to process HCT/Ps has generally been consistent with that guidance, with a few exceptions. Under 21 CFR 878.5040, a suction lipoplasty system is a Class II device that is intended for aesthetic body contouring and consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. These devices act by removal of unwanted fat from areas of the body. However, fat transfer devices, that is, devices that process adipose tissue for return to the body, have also been regulated at CDRH and assigned the same product code, MUU, as suction lipoplasty systems. While suction lipoplasty devices for fat removal do not produce an article for return to the body in order to mediate an intended therapeutic effect, the output of fat transfer devices is returned to the body in order to mediate the intended therapeutic effect (e.g., administration of fat for the purpose of body contouring). Accordingly, we are transferring fat transfer devices identified by product code MUU to CBER so that these devices are regulated by the same center that regulates other devices that process HCT/Ps where the device output (HCT/ P) mediates the intended therapeutic effect. PO 00000 Frm 00017 Fmt 4703 Sfmt 9990 50887 This transfer does not include the suction lipoplasty devices previously in product code MUU that are solely intended to remove fat for discard for the purpose of body contouring. These devices have been assigned a new product code, QPB, and will continue to be regulated by CDRH. For the transferred MUU products, submissions, communications, and required reports should be directed to CBER. Submissions, communications, and required reports for the QPB products should continue to be directed to CDRH. Additionally, CDRH will continue to handle submissions under review or on hold (i.e., received prior to the publication date of this Federal Register document) for MUU products until a final decision is reached. Subsequent submissions for MUU products will be directed to CBER. II. Reference The following references are on display in the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500 and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https:// www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. SMG (FDA Staff Manual Guides) 1410.406, ‘‘Determination of Classification of Devices,’’ November 13, 2018. https://www.fda.gov/media/80114/ download. 2. ‘‘Guidance for industry and FDA staff Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),’’ July 2007. https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/devicesused-process-human-cells-tissues-andcellular-and-tissue-based-productshctps. Authority: 21 U.S.C. 321(h). Dated: August 27, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–18912 Filed 9–10–21; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50886-50887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0104]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: 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.

DATES: Approval is withdrawn as of September 13, 2021.

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 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: 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 Sec.  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 Sec.  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.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
      Application No.                Drug                NDA Holder
------------------------------------------------------------------------
NDA 016401................  Neopap                 PolyMedica Industries
                             (acetaminophen)        Inc., 2 Constitution
                             Suppositories, 120     Way, Woburn, MA
                             milligrams (mg).       01801.
NDA 050266................  Achromycin             Storz Ophthalmics
                             (tetracycline          Inc. (subsidiary of
                             hydrochloride (HCl))   American Cyanamid
                             Ophthalmic Ointment,   Co.), 401 North
                             10 mg/gram.            Middletown Rd.,
                                                    Pearl River, NY
                                                    10965.
NDA 050268................  Achromycin             Do.
                             (tetracycline HCl)
                             Ophthalmic
                             Suspension, 1%.
------------------------------------------------------------------------

    FDA finds that the holders of the NDAs listed in table 1 have 
repeatedly failed to submit reports required by Sec.  314.81. In 
addition, under Sec.  314.200, FDA finds that the holders of the NDAs 
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 supplements thereto is hereby 
withdrawn as of September 13, 2021.


[[Page 50887]]


    Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19689 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P