Notice2023-26445
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
December 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 230 (Friday, December 1, 2023)</title>
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[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83949-83952]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26445]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3007]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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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[[Page 83950]]
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 2, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0776. Also include the FDA docket
number found in brackets in the heading of this document.
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, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="643436253710050202240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Registration of Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act (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 of the FD&C Act 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 our 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 of the FD&C Act.
B. Registration Fees
Upon registration, and in accordance with sections 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#4a090e0f18092526262f293e232524390a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="490a0d0c1b0a2625252c2a3d2026273a092f2d286721213a672e263f">[email 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 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
[[Page 83951]]
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#92d1d6d7c0d1fdfefef7f1e6fbfdfce1d2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="0546414057466a69696066716c6a6b76456361642b6d6d762b626a73">[email 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>.
In the Federal Register of August 15, 2023 (88 FR 55464), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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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 Electronic 1 1 1 1............... 1
Submission of Registration
Information; 207.65; Section
VI. of the ``eDRLS'' \2\
guidance.
Remission of Annual 76 1 76 0.5 (30 minutes) 38
Establishment Fee from FDA
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 (30 minutes) 6
of the Fees for Human Drug
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.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Retention of Small Business 18 1 18 0.5 (30 minutes) 9
Designation Notification
Letter.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 83952]]
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: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26445 Filed 11-30-23; 8:45 am]
BILLING CODE 4164-01-P
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