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
| Published date | 18 November 2020 |
| Citation | 85 FR 73483 |
| Record Number | 2020-25411 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 223 (Wednesday, November 18, 2020)
[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
