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, 73483-73485 [2020-25411]
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
proposed generic and follow-on
versions of SPIRIVA HANDIHALER or
any other Boehringer Ingelheim oral
inhalation product containing the active
ingredient tiotropium bromide under
section 505(j) and (b)(2), respectively, of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j) and (b)(2)) (Docket
No. FDA–2012–P–1072). FDA is
reviewing the issues raised in the
petition and will consider any
comments on the draft guidance entitled
‘‘Draft Guidance for Tiotropium
Bromide’’ before responding to
Boehringer’s citizen petition.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the information and data to
demonstrate BE to support ANDAs for
tiotropium bromide inhalation spray. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Esomeprazole Strontium DelayedRelease Capsules, Equivalent to (EQ) 20
milligrams (mg) base and EQ 40 mg
base, after receiving a withdrawal
request from R2 Pharma, LLC, 11550
North Meridian St., Suite 290, Carmel,
IN 46032–5505 (R2 Pharma). Because of
clerical errors in the Agency’s
processing of communications regarding
this application, FDA has determined
that NDA 202342 remains approved.
Accordingly, FDA’s approval of NDA
202342 remains in effect. There are no
changes with respect to the other 18
NDA withdrawals announced in the
January 8, 2020 Federal Register notice.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Correction
SUPPLEMENTARY INFORMATION:
In the Federal Register of Wednesday,
January 8, 2020 (85 FR 915), appearing
on page 916 in FR Doc. 2020–00075, the
following correction is made:
On page 916, in the table, the entry for
NDA 202342 is removed.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25413 Filed 11–17–20; 8:45 am]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
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VerDate Sep<11>2014
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Jkt 253001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
A. Registration
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:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on January 8, 2020. The
document announced the withdrawal of
approval of 19 new drug applications
(NDAs) from multiple applicants,
withdrawn as of February 7, 2020. The
document indicated that FDA was
withdrawing approval of NDA 202342,
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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).
BILLING CODE 4164–01–P
Food and Drug Administration
Pharmacia and Upjohn Co., et al.;
Withdrawal of Approval of 19 New
Drug Applications; Correction
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2013–N–1429]
[Docket No. FDA–2019–N–5843]
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.
DATES:
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.
[FR Doc. 2020–25412 Filed 11–17–20; 8:45 am]
BILLING CODE 4164–01–P
73483
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18NON1.SGM
18NON1
73484
Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
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 § 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.
In the Federal Register of August 20,
2020 (85 FR 51442), we published a 60day 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
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submission of Registration Information
Using the SPL Format.
Waiver Request From Electronic Submission of Registration Information.
Subtotal.
Remission of Annual Establishment Fee From FDA
Invoice.
Request for Small Business Reduction (Form FDA
3908).
Reinspection Fees .......................................................
VerDate Sep<11>2014
17:59 Nov 17, 2020
Number of
responses per
respondent
Number of
respondents
Activity
Jkt 253001
PO 00000
Frm 00030
Average
burden per
response
Total annual
responses
Total hours
70
1
70
4.5 ..........................
315
1
1
1
1 .............................
1
70
1
70
0.5 (30 minutes) .....
35
15
1
15
25 ...........................
375
14
1
14
0.5 (30 minutes) .....
7
Fmt 4703
Sfmt 4703
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
73485
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Reconsideration Requests ..........................................
Appeal of Reconsideration Denials .............................
3
1
1
1
1
1
1 .............................
1 .............................
3
1
Total ......................................................................
........................
........................
101
................................
421
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Retention of small business designation notification
letter.
15
1
15
0.5 (30 minutes) .....
7.5
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1137 and FDA–
2020–D–1138]
khammond on DSKJM1Z7X2PROD with NOTICES
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
SUMMARY:
VerDate Sep<11>2014
17:59 Nov 17, 2020
Jkt 253001
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on November 18, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
PO 00000
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Sfmt 4703
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 name of the guidance
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. 101 ......................................... 421
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
Activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retention of small business designation 15 1 15 0.5 (30 minutes)....................... 7.5
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.
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
