Document ID: FDA-2020-N-1663-0033
Agency: fda
Document Type: Proposed Rule
Title: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers; Extension of Comment Period
Posted Date: 2022-05-24T04:00Z

[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Proposed Rules]
[Pages 31439-31440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11116]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 12, 16, and 205

[Docket No. FDA-2020-N-1663]
RIN 0910-AH11

National Standards for the Licensure of Wholesale Drug 
Distributors and Third-Party Logistics Providers; Extension of Comment 
Period

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the proposed rule on national 
standards for licensure for wholesale drug distributors and third-party 
logistics providers that appeared in the Federal Register of February 
4, 2022. The Agency is taking this action in response to a request for 
an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the proposed rule 
published February 4, 2022 (87 FR 6708). Submit either electronic or 
written comments by September 6, 2022.

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 September 6, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 6, 2022. 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-2020-N-1663 for ``National Standards for the Licensure of Wholesale 
Drug Distributors and Third-Party Logistics Providers.'' 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: Aaron Weisbuch, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4261, Silver Spring, MD 20993, 301-796-
3130.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 4, 2022 
(87 FR 6708), FDA published a proposed rule proposing to establish 
national standards for licensure for wholesale drug distributors and 
third-party logistics providers. The proposed rule provided a 120-day 
period for submission of public comments.
    The Agency has received a request for a 90-day extension of the 
comment period for the proposed rule. The request conveyed concern that 
the current 120-day comment period, which ends on June 6, 2022, does 
not allow sufficient time to develop a meaningful or thoughtful 
response to the proposed rule.

[[Page 31440]]

    FDA has considered the request and is extending the comment period 
for the proposed rule for 90 days, until September 6, 2022. The Agency 
believes that a 90-day extension allows adequate time for interested 
persons to submit comments.

    Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11116 Filed 5-23-22; 8:45 am]
BILLING CODE 4164-01-P