[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55464-55467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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

[[Page 55465]]

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: 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, 
[email protected].

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 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.

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 
[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

[[Page 55466]]

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 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.
    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                         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.........
                              ----------------------------------------------------------------------------------
    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.

[[Page 55467]]



                                                   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]
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