[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51442-51445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration of Human Drug Compounding Outsourcing 
Facilities under Section 503B of 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 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: Submit either electronic or written comments on the collection 
of information by October 19, 2020.

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 October 19, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 19, 2020. 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-2013-N-1429 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.'' 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

[[Page 51443]]

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 and 
Associated Fees Under Section 503B of the FD&C Act

OMB Control Number 0910-0776--Revision

    This information collection helps to support implementation of 
section 503B of the FD&C Act and the Drug Quality and Security Act 
(DQSA).
A. Registration
    Under section 503B of the FD&C Act (21 U.S.C. 353b), added by DQSA, 
a facility that compounds drugs may elect to register with FDA as an 
outsourcing facility. 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.
    After the initial registration, under section 503B(b) of the FD&C 
Act, a facility that elects to register with FDA as an outsourcing 
facility must also do so annually between October 1 and December 31. 
Upon registration, the outsourcing facility must provide specific 
information including 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 non-sterile drugs from bulk 
drug substances.
    Outsourcing facilities that elect to register submit registration 
information for each facility electronically using a Structured Product 
Labeling (SPL) format in accordance with the FDA guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--Drug 
Establishment Registration and Drug Listing (May 2009).'' The guidance 
is available from our website at: https://www.fda.gov/media/71146/download. Respondents unable to use electronic means to register may 
submit a written request for a waiver from the requirement.
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 (21 U.S.C. 379j-
62), 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, 2020, to qualify for a reduction in the fiscal year 2021 
annual establishment fee.
    Section 744K 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.'' 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, outsourcing facilities are subject 
to inspection and, in accordance with section 744K, 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.

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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. 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),'' 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.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total  annual   Average  burden    Total hours
                                  respondents     respondent       responses      per  response
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Electronic Submission of                    70               1              70  4.5.............             315
 Registration Information
 Using the SPL Format.
Waiver Request From Electronic               1               1               1  1...............               1
 Submission of Registration
 Information.
                               ---------------------------------------------------------------------------------
    Subtotal..................  ..............  ..............  ..............  ................  ..............
Remission of Annual                         70               1              70  0.5 (30 minutes)              35
 Establishment Fee From FDA
 Invoice.
Request for Small Business                  15               1              15  25..............             375
 Reduction (Form FDA 3908).
Reinspection Fees.............              14               1              14  0.5 (30 minutes)               7
Reconsideration Requests......               1               1               1  1...............               1
Appeal of Reconsideration                    1               1               1  1...............               1
 Denials.
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............             101  ................             419
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We estimate 70 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 70 registrants will remit annual establishment fees and assume this 
task requires 30 minutes per respondent. We estimate that 15 of those 
respondents will request a small business reduction in the amount of 
the annual establishment fee using Form FDA 3908.
    We estimate 14 outsourcing facilities annually will remit 
reinspection fees and assume this will require 30 minutes. We also 
estimate that we will receive three requests 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                 15               1              15  0.5 (30 minutes)             7.5
 designation notification
 letter.
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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 15 outsourcing facilities will maintain a 
copy of their small business designation letter and that maintaining 
each record will require 0.5 hour (30 minutes).
    These estimates reflect a slight increase in the number of annual 
registrations, but a decrease in reinspection fee submissions.


[[Page 51445]]


    Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18254 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P