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, 51442-51445 [2020-18254]
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<(1).
Respondents: Federally and staterecognized tribes, Native Pacific
Islanders, Tribal Colleges and
Universities, native non-profits, and
consortia.
ANNUAL BURDEN ESTIMATES
Total number of
respondents
Instrument
Objective Work Plan ........................................
Ongoing Progress Report FY 2020 .................
Ongoing Progress Report FY 2021—Exp.
Date ..............................................................
Total
number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Annual burden
hours
300
200
1
2
3
1
900
400
300
133
200
4
2
1600
533
* Burden is annualized over the three year approval period.
Estimated Total Annual Burden
Hours: 966.
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.
ADDRESSES:
Authority: Sec. 806 [42 U.S.C. 2991d–
1](a)(1) and Sec. 811 [42 U.S.C. 2992].
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–18219 Filed 8–19–20; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1429]
Electronic Submissions
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
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’’).
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 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.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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Written/Paper Submissions
Submit written/paper submissions as
follows:
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• 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
E:\FR\FM\20AUN1.SGM
20AUN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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
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, PRAStaff@
fda.hhs.gov.
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
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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 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.
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
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51443
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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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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. 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
Number of
responses per
respondent
Number of
respondents
Activity
Total
annual
responses
Average
burden per
response
Total hours
Electronic Submission of Registration Information Using the SPL
Format.
Waiver Request From Electronic
Submission of Registration Information.
70
1
70
4.5 .....................................................
315
1
1
1
1 ........................................................
1
Subtotal .....................................
Remission of Annual Establishment
Fee From FDA Invoice.
Request for Small Business Reduction (Form FDA 3908).
Reinspection Fees ............................
Reconsideration Requests ...............
Appeal of Reconsideration Denials ..
........................
70
........................
1
........................
70
...........................................................
0.5 (30 minutes) ...............................
........................
35
15
1
15
25 ......................................................
375
14
1
1
1
1
1
14
1
1
0.5 (30 minutes) ...............................
1 ........................................................
1 ........................................................
7
1
1
Total ...................................
........................
........................
101
...........................................................
419
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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Retention of small business designation notification letter.
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
Activity
15
Total
annual
records
1
Average
burden per
recordkeeping
15
Total hours
0.5 (30 minutes) ...............................
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
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letter and that maintaining each record
will require 0.5 hour (30 minutes).
These estimates reflect a slight
increase in the number of annual
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registrations, but a decrease in
reinspection fee submissions.
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1727]
Public Meeting on the Center for Drug
Evaluation and Research Standard
Core Sets: Clinical Outcome
Assessments and Endpoints Grant
Program—Summer 2020; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following virtual
public meeting entitled ‘‘Public Meeting
on CDER Standard Core Sets: Clinical
Outcome Assessments and Endpoints
Grant Program—Summer 2020.’’ The
purpose of the public meeting is to
ensure that as standard core sets of
clinical outcome assessments (COAs)
are developed as part of the FDA pilot
grant program, the identified concepts,
COAs, and endpoints reflect what is
most important to patients and relevant
to regulatory and potentially other
stakeholder decision making. To
facilitate this, stakeholders including
patients, care partners, FDA reviewers,
drug developers, as well as other
government and academic researchers,
health care providers, health technology
assessors and health payers are
encouraged to attend the meeting.
DATES: The public meeting will be held
on Friday, August 28, 2020, from 8:30
a.m. to 12:30 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by Wednesday,
October 28, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
public meeting via an online
teleconferencing platform.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1727.
The docket will close on October 28,
2020. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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on or before Wednesday, October 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of Wednesday, October 28,
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–
2020–N–1727 for ‘‘Public Meeting on
CDER Standard Core Sets Clinical
Outcome Assessments and Endpoints
Grant Program—Summer 2020.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
PO 00000
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51445
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
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:
Lyna Merzoug, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–6001, CDER_StandardCoreCOAs@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
As part of our Patient Focused Drug
Development (PFDD) efforts, FDA
developed a pilot grant program to
support the development of publicly
available standard core set(s) of COAs
E:\FR\FM\20AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 51444]]
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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Retention of small business 15 1 15 0.5 (30 minutes) 7.5
designation notification
letter.
----------------------------------------------------------------------------------------------------------------
\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
