Document ID: FDA-2023-N-3007-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2023-12-01T05:00Z

[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83949-83952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding, 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 
[email protected]. Form FDA 3908 is available from our 
website at: https://www.fda.gov/media/90740/download. 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 https://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees.

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 https://www.fda.gov/media/87570/download and https://www.fda.gov/media/136683/download, respectively.
    All requests for dispute resolution should be sent via email to the 
Division of User Fee Management and Budget Formulation at 
[email protected]. 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: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm382846.htm.
    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.
                               ---------------------------------------------------------------------------------
    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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing).

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