Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing, 73296-73298 [2021-27946]

Download as PDF 73296 Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–D–0367 for ‘‘Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24).’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed VerDate Sep<11>2014 19:11 Dec 23, 2021 Jkt 256001 confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to Division of Seafood Safety (HFS–325), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood Safety (HFS–325), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–5316, email: steven.bloodgood@fda.hhs.gov; or Jessica Larkin, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: I. Background Frm 00060 Fmt 4703 II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: December 21, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–28053 Filed 12–23–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1252] Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) and is announcing an opportunity for the NDA holders to SUMMARY: We are announcing the availability of a draft Compliance Policy Guide (CPG) entitled ‘‘Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine (CPG 7108.24).’’ This draft PO 00000 CPG would update and replace existing guidance for FDA staff on adulteration associated with decomposition and histamine identified during surveillance sampling and testing of fish and fishery products susceptible to scombrotoxin (histamine) formation. The draft CPG would revise FDA regulatory action guidance for sensory analysis and/or histamine levels in scombrotoxinforming fish and fishery products. We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. Sfmt 4703 E:\FR\FM\27DEN1.SGM 27DEN1 Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for those NDAs. DATES: The NDA holders may submit a request for a hearing by January 26, 2022. Submit all data, information, and analyses upon which the request for a hearing relies February 25, 2022. Submit electronic or written comments by February 25, 2022. ADDRESSES: The request for a hearing may be submitted by the NDA holders by either of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments to submit your request for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a hearing, will be posted to the docket unchanged. khammond on DSKJM1Z7X2PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. The request for a hearing must include the Docket No. FDA–2021–N–1252 for ‘‘Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing.’’ The request for a hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. The NDA holders may submit all data and analyses upon which the request for a hearing relies in the same manner as the request for a hearing except as follows: • Confidential Submissions—To submit any data analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as VerDate Sep<11>2014 19:11 Dec 23, 2021 Jkt 256001 a written/paper submission. You should submit two copies total of all data and analyses. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov or available at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Submit both copies to the Dockets Management Staff. Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties, submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 73297 • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–N–1252 for ‘‘Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing.’’ Received comments, those filed in a timely manner (see DATES, will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. E:\FR\FM\27DEN1.SGM 27DEN1 73298 Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices 796–3137, Kimberly.Lehrfeld@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Kimberly 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– The holder of an approved NDA to market a new drug for human use is required to submit annual reports to FDA concerning its approved NDA under SUPPLEMENTARY INFORMATION: §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). The holders of the approved NDAs listed in Table 1 have repeatedly failed to submit the required annual reports and have not responded to the Agency’s request for submission of the reports. khammond on DSKJM1Z7X2PROD with NOTICES TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED Application No. Drug NDA holder NDA 008284 .......... Cortisone Acetate Tablets, 5 milligrams (mg) and 25 mg ..... NDA 009659 .......... NDA 019503 .......... Hydrocortisone Tablets, 10 mg and 20 mg ........................... Triamcinolone Acetonide Suspension, 3 mg/milliliters (mL) .. Panray Corp. Sub Ormont Drug and Chemical Co., Inc., 520 South Dean St., Englewood, NJ 07631. Do. Parnell Pharmaceuticals Inc., 111 Francisco Blvd., San Rafael, CA 94901. Therefore, notice is given to the holders of the approved NDAs listed in table 1 and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of the NDAs and all amendments and supplements thereto on the grounds that the NDA holders have failed to submit reports required under § 314.81. In accordance with section 505 of the FD&C Act and 21 CFR part 314, the NDA holders are hereby provided an opportunity for a hearing to show why the approval of the NDAs listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these NDAs. An NDA holder who decides to seek a hearing must file the following: (1) A written notice of participation and request for a hearing (see DATES and ADDRESSES) and (2) the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES and ADDRESSES). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, the information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 (21 CFR 314.200) and in 21 CFR part 12. The failure of an NDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that NDA holder not to avail itself of the opportunity for a hearing concerning CDER’s proposal to withdraw approval of the NDAs and constitutes a waiver of any contentions concerning the legal VerDate Sep<11>2014 19:11 Dec 23, 2021 Jkt 256001 status of the drug products. FDA will then withdraw approval of the NDAs, and the drug products may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved NDA is subject to regulatory action at any time. A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing. All paper submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs. Dated: December 20, 2021. Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research. [FR Doc. 2021–27946 Filed 12–23–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1118] Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).’’ This guidance identifies the key features of nonclinical and clinical investigational plans used to support investigational device exemption applications, premarket approval applications, De Novo classification requests, and some premarket notification submissions for devices used in the treatment of BPH. DATES: The announcement of the guidance is published in the Federal Register on December 27, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73296-73298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27946]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1252]


Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; 
Proposal To Withdraw Approval of Three New Drug Applications; 
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of three new drug applications (NDAs) and is announcing an opportunity 
for the NDA holders to

[[Page 73297]]

request a hearing on this proposal. The basis for the proposal is that 
the NDA holders have repeatedly failed to file required annual reports 
for those NDAs.

DATES: The NDA holders may submit a request for a hearing by January 
26, 2022. Submit all data, information, and analyses upon which the 
request for a hearing relies February 25, 2022. Submit electronic or 
written comments by February 25, 2022.

ADDRESSES: The request for a hearing may be submitted by the NDA 
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third party may not 
wish to be posted, such as medical information, your or anyone else's 
Social Security number, or confidential business information, such as a 
manufacturing process. The request for a hearing must include the 
Docket No. FDA-2021-N-1252 for ``Panray Corp. Sub Ormont Drug and 
Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New 
Drug Applications; Opportunity for a Hearing.'' The request for a 
hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    The NDA holders may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
any decisions on this matter. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday, 240-402-7500. Submit both copies to the Dockets 
Management Staff. Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-1252 for ``Panray Corp. Sub Ormont Drug and Chemical Co., 
Inc., et al.; Proposal To Withdraw Approval of Three New Drug 
Applications; Opportunity for a Hearing.'' Received comments, those 
filed in a timely manner (see DATES, will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

[[Page 73298]]


FOR FURTHER INFORMATION CONTACT: Kimberly 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 NDA to market a 
new drug for human use is required to submit annual reports to FDA 
concerning its approved NDA under Sec. Sec.  314.81 and 314.98 (21 CFR 
314.81 and 314.98). The holders of the approved NDAs listed in Table 1 
have repeatedly failed to submit the required annual reports and have 
not responded to the Agency's request for submission of the reports.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
     Application No.               Drug                 NDA holder
------------------------------------------------------------------------
NDA 008284..............  Cortisone Acetate       Panray Corp. Sub
                           Tablets, 5 milligrams   Ormont Drug and
                           (mg) and 25 mg.         Chemical Co., Inc.,
                                                   520 South Dean St.,
                                                   Englewood, NJ 07631.
NDA 009659..............  Hydrocortisone          Do.
                           Tablets, 10 mg and 20
                           mg.
NDA 019503..............  Triamcinolone           Parnell
                           Acetonide Suspension,   Pharmaceuticals Inc.,
                           3 mg/milliliters (mL).  111 Francisco Blvd.,
                                                   San Rafael, CA 94901.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved NDAs 
listed in table 1 and to all other interested persons that the Director 
of CDER proposes to issue an order, under section 505(e) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing 
approval of the NDAs and all amendments and supplements thereto on the 
grounds that the NDA holders have failed to submit reports required 
under Sec.  314.81.
    In accordance with section 505 of the FD&C Act and 21 CFR part 314, 
the NDA holders are hereby provided an opportunity for a hearing to 
show why the approval of the NDAs listed previously should not be 
withdrawn and an opportunity to raise, for administrative 
determination, all issues relating to the legal status of the drug 
products covered by these NDAs.
    An NDA holder who decides to seek a hearing must file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, notice of participation and request for a 
hearing, the information and analyses to justify a hearing, other 
comments, and a grant or denial of a hearing are contained in Sec.  
314.200 (21 CFR 314.200) and in 21 CFR part 12.
    The failure of an NDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that NDA holder not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the NDAs and constitutes a waiver of any contentions 
concerning the legal status of the drug products. FDA will then 
withdraw approval of the NDAs, and the drug products may not thereafter 
be lawfully introduced or delivered for introduction into interstate 
commerce. Any new drug product introduced or delivered for introduction 
into interstate commerce without an approved NDA is subject to 
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials but must present specific facts showing that there is a genuine 
and substantial issue of fact that requires a hearing. If a request for 
a hearing is not complete or is not supported, the Commissioner of Food 
and Drugs will enter summary judgment against the person who requests 
the hearing, making findings and conclusions, and denying a hearing.
    All paper submissions under this notice of opportunity for a 
hearing must be filed in two copies. Except for data and information 
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 
1905, the submissions may be seen at the Dockets Management Staff (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: December 20, 2021.
Jacqueline Corrigan-Curay,
Principal Deputy Center Director, Center for Drug Evaluation and 
Research.
[FR Doc. 2021-27946 Filed 12-23-21; 8:45 am]
BILLING CODE 4164-01-P
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