Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees

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Published

August 15, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

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<title>Federal Register, Volume 88 Issue 156 (Tuesday, August 15, 2023)</title>
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[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55464-55467]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17458]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3007]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Human Drug Compounding Outsourcing
Facilities Under the Federal Food, Drug, and Cosmetic Act and
Associated Fees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection pertaining to
the registration of human drug compounding outsourcing facilities under
the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated
fees.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 16, 2023

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 16, 2023 Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-3007 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Human Drug
Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
and Associated Fees Under Section 744K.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the

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electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-793-5733,
<a href="/cdn-cgi/l/email-protection#49191b081a3d282f2f092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="4d1d1f0c1e392c2b2b0d2b292c6325253e632a223b">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Registration of Human Drug Compounding Outsourcing Facilities Under
Section 503B of the FD&C Act and Associated Fees Under Section 744K

OMB Control Number 0910-0776--Extension

This information collection helps to support implementation of
section 503B of the FD&C Act (21 U.S.C. 353b) and the assessment and
remission of user fees under section 744K of the FD&C Act (21 U.S.C.
379j-62).

A. Registration

Under section 503B of the FD&C Act a facility that compounds drugs
may elect to register with FDA as an outsourcing facility. Upon
electing to do so, outsourcing facilities must register annually
between October 1 and December 31, providing information that includes
its name, place of business, a unique facility identifier, and a point
of contact's email address and phone number. The outsourcing facility
must also indicate: (1) whether it intends to compound, within the next
calendar year, a drug that appears on our drug shortage list in effect
under section 506E of the FD&C Act (21 U.S.C. 356e); and (2) whether it
compounds from bulk drug substances and, if so, whether it compounds
sterile or nonsterile drugs from bulk drug substances. Registered
outsourcing facilities must submit a drug product report upon initial
registration under section 503B and twice each year in June and
December for drug products produced during the previous 6-month period.
We require this data be submitted electronically, unless a waiver is
granted, in structured product labeling (SPL) format.
Drug products compounded in a registered outsourcing facility can
qualify for exemptions from the FDA-approval requirements in section
505 of the FD&C Act (21 U.S.C. 355), the requirement to label products
with adequate directions for use under section 502(f)(1) of the FD&C
Act (21 U.S.C. 352(f)(1)), and the requirements for drug supply chain
security in section 582 of the FD&C Act (21 U.S.C. 360eee-1) if the
requirements in section 503B of the FD&C Act have been met. We provide
general information and resources on website at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding</a>, including a list of currently registered outsourcing
facilities as required under section 503B.

B. Registration Fees

Upon registration, and in accordance with section 503B and 744K of
the FD&C Act, facilities are assessed an establishment fee and receive
an annual invoice from FDA with instructions for remitting payment.
Until payment is made for each given fiscal year (FY), an establishment
is not considered to be registered as an outsourcing facility. In
accordance with section 744K of the FD&C Act, certain outsourcing
facilities may qualify for a small business reduction in the amount of
the annual establishment fee. To qualify for this reduction, an
outsourcing facility must submit a written request to FDA certifying
that the entity meets the requirements for the reduction. For each FY a
firm seeks to qualify as a small business and receive the fee
reduction, it must submit to FDA a written request by April 30 of the
preceding FY. For example, an outsourcing facility must have submitted
a written request for the small business reduction by April 30, 2023,
to qualify for a reduction in the FY 2024 annual establishment fee.
Section 744K of the FD&C Act also requires an outsourcing facility
to submit written requests for a small business reduction in a
specified format: Form FDA 3908 entitled ``Outsourcing Facilities for
Human Drug Compounding: Small Business Establishment Fee Reduction
Request.'' The completed form should be submitted via email to
<a href="/cdn-cgi/l/email-protection#91d2d5d4c3d2fefdfdf4f2e5f8feffe2d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="8ecdcacbdccde1e2e2ebedfae7e1e0fdcee8eaefa0e6e6fda0e9e1f8">[email&#160;protected]</span></a>. Form FDA 3908 is available from our
website at: <a href="https://www.fda.gov/media/90740/download">https://www.fda.gov/media/90740/download</a>. In response to
the submission of a small business reduction request, FDA will send a
notification letter of its decision and recommends that applicants
retain the notification.

C. Reinspection Fees

In accordance with section 503B of the FD&C Act, outsourcing
facilities are subject to inspection and, in accordance with section
744K of the FD&C Act, subject to reinspection fees. A reinspection fee
will be incurred for each reinspection and is intended to reimburse FDA
when a particular outsourcing facility requires reinspection because of
noncompliance identified during a previous inspection. After a
reinspection is conducted, FDA will send an invoice to the email
address indicated in the facility's registration file. The invoice
contains instructions for remitting the reinspection fee. For further
information on human drug compounding outsourcing facility fees, please
visit our

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website at <a href="https://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees">https://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees</a>.

D. Dispute Resolution

Agency regulations under Sec. 10.75 (21 CFR 10.75) provide for
internal Agency review of decisions. Accordingly, an outsourcing
facility may request reconsideration of an FDA decision related to the
fee provisions of section 744K of the FD&C Act. Requests for
reconsideration should include the facility's rationale for its
position that FDA's decision was in error and include any additional
information that is relevant to the outsourcing facility's assertion.
The denial of a request for reconsideration may be appealed by
submitting a written request to FDA, consistent with Sec. 10.75.
To assist respondents with the information collection provisions,
we have developed Agency guidance documents. The guidance document
entitled ``Registration of Human Drug Compounding Outsourcing
Facilities Under Section 503B of the FD&C Act (November 2014)''
describes the process for electronic submission of establishment
registration information for outsourcing facilities and provides
information on how to obtain a waiver from submitting registration
information electronically. The guidance document entitled ``Fees for
Human Drug Compounding Outsourcing Facilities Under Sections 503B and
744K of the FD&C Act (November 2014)'' (Fees for Human Drug Compounding
Outsourcing Facilities guidance) describes the types and amounts of
fees that outsourcing facilities must pay, the adjustments to fees
required by law, how outsourcing facilities can submit payment to FDA,
the consequences of outsourcing facilities' failure to pay fees, and
how an outsourcing facility can qualify as a small business to obtain a
reduction in fees. The guidance documents were issued consistent with
our good guidance practice regulations (21 CFR 10.115), which provide
for public comment at any time, and are available on our website at
<a href="https://www.fda.gov/media/87570/download">https://www.fda.gov/media/87570/download</a> and <a href="https://www.fda.gov/media/136683/download">https://www.fda.gov/media/136683/download</a>, respectively.
All requests for dispute resolution should be sent via email to the
Division of User Fee Management and Budget Formulation at
<a href="/cdn-cgi/l/email-protection#7033343522331f1c1c151304191f1e03301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="83c0c7c6d1c0ecefefe6e0f7eaecedf0c3e5e7e2adebebf0ade4ecf5">[email&#160;protected]</span></a>. If an outsourcing facility does not have
email access, it can mail a request to FDA via the carrier of its
choice. For the most updated physical mailing address, visit this
website: <a href="https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm382846.htm">https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm382846.htm</a>.
We estimate the burden of the information collection as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Activity; 21 CFR section; Number of
guidance or associated FDA Number of responses per Total annual Average burden Total hours
form respondents respondent responses per response
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Electronic Submission of 79 1 79 4.5 355
Registration Information
Using the SPL Format;
207.61; Section III. of the
``eDRLS'' \2\ guidance......
Waiver Request from 1 1 1 1 1
Electronic Submission of
Registration Information;
207.65; Section VI. of the
``eDRLS'' \2\ guidance......
Remission of Annual 76 1 76 0.5 38
Establishment Fee from FDA (30 minutes)
Invoice; Section E.1. of the
Fees for Human Drug
Compounding Outsourcing
Facilities guidance.........
Request for Small Business 18 1 18 25 450
Reduction (Form FDA 3908)...
Reinspection Fees; Section C. 12 1 12 0.5 6
of the Fees for Human Drug (30 minutes)
Compounding Outsourcing
Facilities guidance.........
Reconsideration Requests; 1 1 1 1 1
Section V.B.1. of the Fees
for Human Drug Compounding
Outsourcing Facilities
guidance....................
Appeal of Reconsideration 1 1 1 1 1
Denials; Section V.B.2. of
the Fees for Human Drug
Compounding Outsourcing
Facilities guidance.........
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Total.................... .............. .............. 188 ................. 852
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing''
(May 2009; available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing</a>).

We estimate 79 respondents annually will submit outsourcing
facility registrations using the SPL format as specified in Agency
guidance and assume each registration will require 4.5 hours to prepare
and complete. We expect no more than one waiver request from the
electronic submission requirement annually and assume each waiver
request will require 1 hour to prepare and submit. We estimate each of
the 76 registrants will remit annual establishment fees and assume this
task requires 30 minutes per respondent. We estimate that 18 of those
respondents will request a small business reduction in the amount of
the annual establishment fee using Form FDA 3908.
We estimate 12 outsourcing facilities annually will remit
reinspection fees and assume this will require 30 minutes. We also
estimate that we will receive one request for reconsideration and one
appeal of a denial of a request for reconsideration and assume 1 hour
per respondent for this activity.

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Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeping
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Retention of Small Business Designation Notification Letter...... 18 1 18 0.5 9
(30 minutes)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that annually 18 outsourcing facilities will maintain a
copy of their small business designation letter and that maintaining
each record will require 30 minutes. These estimates reflect a slight
increase in the number of annual registrations, but a decrease in
reinspection fee submissions.

Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17458 Filed 8-14-23; 8:45 am]
BILLING CODE 4164-01-P

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