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, 55464-55467 [2023-17458]
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Federal Register / Vol. 88, No. 156 / Tuesday, August 15, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Voluntary consensus standards recognition program for
regenerative medicine therapies; guidance for industry
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for recognition of a voluntary consensus standard
and submission of information as specified in Section V
9
1
9
3
27
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on our
experience with similar information
collection activities. We note that
standards development can be a lengthy
process and provide an estimate we
believe reflects the amount of time
necessary to prepare and submit the
information as discussed in Section V of
the guidance document.
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17460 Filed 8–14–23; 8:45 am]
Electronic Submissions
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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Comments submitted electronically,
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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.
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
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
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.
ADDRESSES:
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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
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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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\15AUN1.SGM
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Federal Register / Vol. 88, No. 156 / Tuesday, August 15, 2023 / Notices
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, PRAStaff@
fda.hhs.gov.
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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 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.
SUPPLEMENTARY INFORMATION:
Registration of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the FD&C Act
and Associated Fees Under Section
744K
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 FDAapproval 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/guidancecompliance-regulatory-information/
human-drug-compounding, including a
list of currently registered outsourcing
facilities as required under section
503B.
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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
CDERCollections@fda.hhs.gov. 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
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website at https://www.fda.gov/
industry/fda-user-fee-programs/humandrug-compounding-outsourcing-facilityfees.
D. Dispute Resolution
Agency regulations under § 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 § 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 CDERCollections@
fda.hhs.gov. 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/officeofmedical
productsandtobacco/cder/
ucm382846.htm.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity; 21 CFR section;
guidance or associated FDA form
Number of
responses per
respondent
Number of
respondents
Electronic Submission of Registration Information
Using the SPL Format; 207.61; Section III. of the
‘‘eDRLS’’ 2 guidance ...................................................
Waiver Request from Electronic Submission of Registration Information; 207.65; Section VI. of the
‘‘eDRLS’’ 2 guidance ...................................................
Remission of Annual Establishment Fee from FDA Invoice; Section E.1. of the Fees for Human Drug
Compounding Outsourcing Facilities guidance ..........
Total hours
79
1
79
4.5
355
1
1
1
1
1
76
1
76
0.5
(30 minutes)
38
18
1
18
25
450
12
1
12
0.5
(30 minutes)
6
1
1
1
1
1
1
1
1
1
1
........................
........................
188
..............................
852
Request for Small Business Reduction (Form FDA
3908) ..........................................................................
Reinspection Fees; Section C. of the Fees for Human
Drug Compounding Outsourcing Facilities guidance
Reconsideration Requests; Section V.B.1. of the Fees
for Human Drug Compounding Outsourcing Facilities guidance ..............................................................
Appeal of Reconsideration Denials; Section V.B.2. of
the Fees for Human Drug Compounding Outsourcing Facilities guidance ................................................
Total ........................................................................
Average
burden
per response
Total annual
responses
1 There
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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
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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.
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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.
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Federal Register / Vol. 88, No. 156 / Tuesday, August 15, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Retention of Small Business Designation Notification
Letter ..........................................................................
18
1
18
1 There
Total hours
0.5
(30 minutes)
9
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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Average
burden per
recordkeeping
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov/).
A portion of this meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
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Date: September 7, 2023.
Closed: 10:30 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Open: 11:00 a.m. to 4:00 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, Conference Rooms A, B & C,
6700B Rockledge Drive Bethesda, MD 20817.
Contact Person: Ranga V. Srinivas, Ph.D.,
Acting Executive Secretary, Extramural
Project Review Branch, National Institute on
Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive
Room 2114, Bethesda, MD 20892, (301) 451–
2067 srinivar@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/
AdvisoryCouncil/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.273, Alcohol Research
Programs, National Institutes of Health, HHS)
Dated: August 10, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–17488 Filed 8–14–23; 8:45 am]
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Human
Studies of Diabetes and Obesity.
Date: September 1, 2023.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Hui Chen, MD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6164, Bethesda, MD 20892, 301–
435–1044, chenhui@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 10, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–17487 Filed 8–14–23; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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DEPARTMENT OF HOMELAND
SECURITY
[Docket Number DHS–2023–0027]
Agency Information Collection
Activities: Personal Identity
Verification Official (PIV–O) Credential
and Shield Request, OMB Control No.
1601–NEW
Department of Homeland
Security (DHS).
ACTION: 60-Day notice and request for
comments.
AGENCY:
The Department of Homeland
Security will submit the following
Information Collection Request (ICR) to
the Office of Management and Budget
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retention of Small Business Designation Notification Letter...... 18 1 18 0.5 9
(30 minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4164-01-P
