[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73483-73485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 December 18, 2020.

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, 10 a.m.-12 p.m., 
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 and Associated 
Fees

OMB Control Number 0910-0776--Revision

    This information collection helps to support implementation of 
section 503B of the Federal Food, Drug, and Cosmetic Act (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

[[Page 73484]]

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 of the FD&C Act, 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.
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.
    In the Federal Register of August 20, 2020 (85 FR 51442), we 
published a 60-day notice requesting public 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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                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Electronic Submission of Registration                      70               1              70  4.5......................................             315
 Information Using the SPL Format.
Waiver Request From Electronic Submission of                1               1               1  1........................................               1
 Registration Information.
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    Subtotal.................................
Remission of Annual Establishment Fee From                 70               1              70  0.5 (30 minutes).........................              35
 FDA Invoice.
Request for Small Business Reduction (Form                 15               1              15  25.......................................             375
 FDA 3908).
Reinspection Fees............................              14               1              14  0.5 (30 minutes).........................               7

[[Page 73485]]

 
Reconsideration Requests.....................               3               1               1  1........................................               3
Appeal of Reconsideration Denials............               1               1               1  1........................................               1
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    Total....................................  ..............  ..............             101  .........................................             421
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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
                  Activity                      Number of       records per      Total annual       Average burden per recordkeeping       Total hours
                                              recordkeepers     recordkeeper       records
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Retention of small business designation                  15                1               15   0.5 (30 minutes).......................             7.5
 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.

    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25411 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P