Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures, 49381-49383 [2020-17711]
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Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; 21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Request for HUD designation—814.102 .......................
HDE Application—814.104 ............................................
HDE Amendments and resubmitted HDEs—814.106 ...
HDE Supplements—814.108 .........................................
Notification of withdrawal of an HDE—814.116(e)(3) ...
Notification of withdrawal of IRB approval—814.124(b)
Periodic reports—814.126(b)(1) ....................................
20
4
20
116
2
1
50
1
1
5
1
1
1
1
20
4
100
116
2
1
50
40
328
50
80
1
2
120
800
1,312
5,000
9,280
2
2
6,000
Total ........................................................................
..........................
..........................
........................
..........................
22,396
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity; 21 CFR section
Number of
recordkeepers
Number of
records per
respondent
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ......................................
65
1
65
2
130
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity; 21 CFR section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification of emergency use—814.124(a) ................
22
1
22
1
22
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in tables
1, 2, and 3 are an average based on data
for the previous 3 years, i.e., fiscal years
2017 through 2019. The number of
respondents has been adjusted to reflect
updated respondent data. This has
resulted in an overall increase of 5,809
hours to the total estimated burden. The
number of annual reports submitted
under § 814.126(b)(1) in table 1 reflects
50 respondents with approved HUD
applications. Under § 814.126(b)(2) in
table 2, the estimated number of
recordkeepers is 65.
We have also updated the burden
estimate consistent with new provisions
in § 814.104(b)(4)(i)) regarding ‘‘Human
Subject Protection; Acceptance of Data
from Clinical Investigations for Medical
Devices’’ (83 FR 7366; February 21,
2018) (approved under OMB control
number 0910–0741). Section 814.104 is
being amended to address submission of
data from clinical investigations in a
Humanitarian Device Exemption (HDE).
To the extent the applicant includes
data from clinical investigations, the
applicant will be required to include the
information and statements as described
in § 814.104(b)(4)(i). Consistent with our
estimate in OMB control number 0910–
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17:16 Aug 12, 2020
Jkt 250001
0741, this revision increases our burden
estimate for an HDE by 8 hours per
submission.
Dated: August 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17716 Filed 8–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0076]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
SUMMARY:
PO 00000
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Fmt 4703
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Submit either electronic or
written comments on the collection of
information by October 13, 2020.
DATES:
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 13,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 13, 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:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Records; Electronic Signatures
AGENCY:
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 requirements
governing the acceptance of electronic
records and electronic signatures.
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Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices
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–
2011–N–0076 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Electronic Records; Electronic
Signatures.’’ 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.
• 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
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17:16 Aug 12, 2020
Jkt 250001
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.
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, 301–796–5733, 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
PO 00000
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Sfmt 4703
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.
Electronic Records; Electronic
Signatures—21 CFR Part 11
OMB Control Number 0910–0303—
Extension
This information collection supports
FDA regulations in part 11 (21 CFR part
11), which govern criteria for
acceptance of electronic records,
electronic signatures, and handwritten
signatures executed to electronic
records as equivalent to paper records.
Under these regulations, records and
reports may be submitted to us
electronically provided that we have
stated our ability to accept the records
electronically in an Agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in
§§ 11.10, 11.30, 11.50, and 11.300
require the following standard operating
procedures to ensure appropriate use of
and precautions for systems using
electronic records and signatures: (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify to us in writing that
they will regard electronic signatures
used in their systems as the legally
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49383
Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. We anticipate that the use
of electronic media will substantially
reduce the paperwork burden associated
with maintaining FDA-required records.
The respondents are businesses and
other for-profit organizations, State or
local governments, Federal Agencies,
and nonprofit institutions.
submit designated information
electronically and, as a result, have
become subject to part 11. Part 11
applies to records in electronic form
that are created, modified, maintained,
archived, retrieved, or transmitted
under any records requirements set
forth in Agency regulations. Part 11 also
applies to electronic records submitted
to the Agency under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, even if such records
are not specifically identified in Agency
regulations (§ 11.1).
We estimate the burden of this
collection of information as follows:
To assist respondents with the
information collection we have
developed the guidance document
entitled ‘‘Guidance for Industry: Part 11,
Electronic Records; Electronic
Signatures—Scope and Application,’’
available on our website at https://
www.fda.gov/media/75414/download.
While we do not believe the guidance
creates any attendant burden, it
describes the Agency’s thinking
regarding persons who, in fulfillment of
a requirement in a statute or another
part of FDA’s regulations to maintain
records or submit information to FDA,
have chosen to maintain the records or
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
§ 11.100 ..........................................................................
4,500
1
4,500
1
4,500
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
record per
recordkeepers
Total annual
records
§ 11.10 ............................................................................
§ 11.30 ............................................................................
§ 11.50 ............................................................................
§ 11.300 ..........................................................................
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ........................................................................
..........................
..........................
........................
..........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: August 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17711 Filed 8–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1298]
Acute Myeloid Leukemia: Developing
Drugs and Biological Products for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
17:16 Aug 12, 2020
Jkt 250001
guidance for industry entitled ‘‘Acute
Myeloid Leukemia: Developing Drugs
and Biological Products for Treatment.’’
This draft guidance is intended to assist
sponsors in the clinical development of
drugs and biological products for the
treatment of acute myeloid leukemia
(AML). This draft guidance addresses
FDA’s current thinking regarding the
overall development program and
clinical trial designs for the
development of drugs and biological
products to support an indication of
treatment of AML, including indications
limited to an individual phase of
treatment (for example, maintenance,
transplantation preparative regimen,
etc.). The draft guidance addresses the
topics of general drug development,
efficacy endpoints, and exploratory and
confirmatory trial considerations for
AML drug development. In addition, the
draft guidance addresses investigational
new drug applications, new drug
applications, and biologics licensing
applications for AML drugs.
Submit either electronic or
written comments on the draft guidance
DATES:
PO 00000
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Sfmt 4703
by October 13, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance 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
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
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49381-49383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0076]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Records; Electronic Signatures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 requirements governing the
acceptance of electronic records and electronic signatures.
DATES: Submit either electronic or written comments on the collection
of information by October 13, 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 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 13, 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.
[[Page 49382]]
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-2011-N-0076 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Records; Electronic
Signatures.'' 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.
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 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.
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, 301-796-5733,
[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.
Electronic Records; Electronic Signatures--21 CFR Part 11
OMB Control Number 0910-0303--Extension
This information collection supports FDA regulations in part 11 (21
CFR part 11), which govern criteria for acceptance of electronic
records, electronic signatures, and handwritten signatures executed to
electronic records as equivalent to paper records. Under these
regulations, records and reports may be submitted to us electronically
provided that we have stated our ability to accept the records
electronically in an Agency-established public docket and that the
other requirements of part 11 are met.
The recordkeeping provisions in Sec. Sec. 11.10, 11.30, 11.50, and
11.300 require the following standard operating procedures to ensure
appropriate use of and precautions for systems using electronic records
and signatures: (1) Sec. 11.10 specifies procedures and controls for
persons who use closed systems to create, modify, maintain, or transmit
electronic records; (2) Sec. 11.30 specifies procedures and controls
for persons who use open systems to create, modify, maintain, or
transmit electronic records; (3) Sec. 11.50 specifies procedures and
controls for persons who use electronic signatures; and (4) Sec.
11.300 specifies controls to ensure the security and integrity of
electronic signatures based upon use of identification codes in
combination with passwords. The reporting provision (Sec. 11.100)
requires persons to certify to us in writing that they will regard
electronic signatures used in their systems as the legally
[[Page 49383]]
binding equivalent of traditional handwritten signatures.
The burden created by the information collection provision of this
regulation is a one-time burden associated with the creation of
standard operating procedures, validation, and certification. We
anticipate that the use of electronic media will substantially reduce
the paperwork burden associated with maintaining FDA-required records.
The respondents are businesses and other for-profit organizations,
State or local governments, Federal Agencies, and nonprofit
institutions.
To assist respondents with the information collection we have
developed the guidance document entitled ``Guidance for Industry: Part
11, Electronic Records; Electronic Signatures--Scope and Application,''
available on our website at https://www.fda.gov/media/75414/download.
While we do not believe the guidance creates any attendant burden, it
describes the Agency's thinking regarding persons who, in fulfillment
of a requirement in a statute or another part of FDA's regulations to
maintain records or submit information to FDA, have chosen to maintain
the records or submit designated information electronically and, as a
result, have become subject to part 11. Part 11 applies to records in
electronic form that are created, modified, maintained, archived,
retrieved, or transmitted under any records requirements set forth in
Agency regulations. Part 11 also applies to electronic records
submitted to the Agency under the Federal Food, Drug, and Cosmetic Act
and the Public Health Service Act, even if such records are not
specifically identified in Agency regulations (Sec. 11.1).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 11.100................................................... 4,500 1 4,500 1 4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of record per Total annual per Total hours
recordkeepers recordkeepers records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. 11.10................. 2,500 1 2,500 20 50,000
Sec. 11.30................. 2,500 1 2,500 20 50,000
Sec. 11.50................. 4,500 1 4,500 20 90,000
Sec. 11.300................ 4,500 1 4,500 20 90,000
----------------------------------------------------------------------------------
Total.................... ............... ............... .............. ............... 280,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17711 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P
