List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period, 1515-1516 [2021-00123]

Download as PDF Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 4, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–00124 Filed 1–7–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3240] List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for a notice that appeared in the Federal Register of July 31, 2020, in which FDA identified certain bulk drug substances (active pharmaceutical ingredients) that FDA has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need (the 503B Bulks List). The Agency is taking this action in response to a request received during the initial comment period, which asked the Agency to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the notice published on July 31, 2020 (85 FR 46126). Submit either electronic or written comments by February 8, 2021. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 8, 2021. tkelley on DSKBCP9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:23 Jan 07, 2021 Jkt 253001 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– 2018–N–3240 for ‘‘List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 1515 • 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. FOR FURTHER INFORMATION CONTACT: Dominic Markwordt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993, 301–796– 9349. SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 2020 (85 FR 46126), FDA published a notice that identified four bulk drug substances that FDA considered and proposed to include on the 503B Bulks List: diphenylcyclopropenone (DPCP), glycolic acid, squaric acid dibutyl ester (SADBE), and trichloroacetic acid (TCA). The July 31, 2020, notice also identified 19 bulk drug substances that FDA considered and proposed not to include on the 503B Bulks List: Diazepam, dobutamine hydrochloride E:\FR\FM\08JAN1.SGM 08JAN1 1516 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, hydroxyzine HCl, ketorolac tromethamine, labetalol HCl, mannitol, metoclopramide HCl, moxifloxacin HCl, nalbuphine HCl, polidocanol, potassium acetate, procainamide HCl, sodium nitroprusside, sodium thiosulfate, and verapamil HCl. Interested persons were originally given until September 29, 2020, to comment on FDA’s proposals. During the comment period for the July 31, 2020, notice, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 60 days was insufficient to respond fully to FDA’s specific requests for comments and noted the commenter’s obligations to respond to the exigencies of COVID–19 pandemic. FDA has considered the request and other relevant factors, and accordingly is reopening the comment period for the July 31, 2020, notice for 30 days, until February 8, 2021. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 4, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2021–00123 Filed 1–7–21; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2020–N–2300] Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 006002 ARALEN ................... 500 milligrams (mg) ................... Tablet; Oral ............... NDA 006134 DOLOPHINE HYDROCHLORIDE. BENTYL .................... 5 mg; 10 mg ............................... Tablet; Oral ............... 10 mg ......................................... Capsule; Oral ........... 20 mg ......................................... Tablet; Oral. Equivalent to (EQ) 2.5 mg Base Tablet; Oral ............... NDA 008085 Methotrexate Sodium Chloroquine Phosphate. Methadone Hydrochloride. Dicyclomine Hydrochloride. Dicyclomine Hydrochloride. Methotrexate Sodium NDA 008678 NDA 012945 Isoniazid ................... DIAMOX ................... Isoniazid ................... Acetazolamide .......... 100 mg; 300 mg ......................... 500 mg ....................................... Tablet; Oral ............... Extended-Release Capsule; Oral. NDA 014103 ONCOVIN ................. Vincristine Sulfate ..... Injectable; Injection ... NDA 016792 SURMONTIL ............ Trimipramine Maleate 1 mg/milliliter (mL); 1 mg/Vial; 5 mg/Vial. EQ 25 mg/Base; EQ 50 mg/ Base; EQ 100 mg/Base. NDA 007409 tkelley on DSKBCP9HB2PROD with NOTICES Food and Drug Administration which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. VerDate Sep<11>2014 21:23 Jan 07, 2021 Jkt 253001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Capsule; Oral ........... E:\FR\FM\08JAN1.SGM 08JAN1 Applicant Sanofi-Aventis U.S. LLC. Hikma Pharmaceuticals PLC. Allergan Pharmaceuticals. DAVA Pharmaceuticals, Inc. Sandoz. Teva Branded Pharmaceutical Products. Eli Lilly and Co. Teva Women’s Health, Inc.

Agencies

[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1515-1516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3240]


List of Bulk Drug Substances for Which There Is a Clinical Need 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for a notice that appeared in the Federal 
Register of July 31, 2020, in which FDA identified certain bulk drug 
substances (active pharmaceutical ingredients) that FDA has considered 
and proposes to include or not include on the list of bulk drug 
substances for which there is a clinical need (the 503B Bulks List). 
The Agency is taking this action in response to a request received 
during the initial comment period, which asked the Agency to allow 
interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the notice published on 
July 31, 2020 (85 FR 46126). Submit either electronic or written 
comments by February 8, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 8, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2018-N-3240 for ``List of Bulk Drug Substances for Which There is a 
Clinical Need Under Section 503B of the Federal Food, Drug, and 
Cosmetic Act.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Dominic Markwordt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993, 301-796-
9349.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 2020 (85 
FR 46126), FDA published a notice that identified four bulk drug 
substances that FDA considered and proposed to include on the 503B 
Bulks List: diphenylcyclopropenone (DPCP), glycolic acid, squaric acid 
dibutyl ester (SADBE), and trichloroacetic acid (TCA). The July 31, 
2020, notice also identified 19 bulk drug substances that FDA 
considered and proposed not to include on the 503B Bulks List: 
Diazepam, dobutamine hydrochloride

[[Page 1516]]

(HCl), dopamine HCl, edetate calcium disodium, folic acid, 
glycopyrrolate, hydroxyzine HCl, ketorolac tromethamine, labetalol HCl, 
mannitol, metoclopramide HCl, moxifloxacin HCl, nalbuphine HCl, 
polidocanol, potassium acetate, procainamide HCl, sodium nitroprusside, 
sodium thiosulfate, and verapamil HCl. Interested persons were 
originally given until September 29, 2020, to comment on FDA's 
proposals.
    During the comment period for the July 31, 2020, notice, FDA 
received a request to allow interested persons additional time to 
comment. The requester asserted that the time period of 60 days was 
insufficient to respond fully to FDA's specific requests for comments 
and noted the commenter's obligations to respond to the exigencies of 
COVID-19 pandemic.
    FDA has considered the request and other relevant factors, and 
accordingly is reopening the comment period for the July 31, 2020, 
notice for 30 days, until February 8, 2021. The Agency believes that an 
additional 30 days will allow adequate time for interested persons to 
submit comments.

    Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00123 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P
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