Document ID: FDA-2018-N-3240-0274
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-01-08T05:00Z

[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.

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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