Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 77223-77224 [2020-26487]
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Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
dependent DDI studies, alternative
approaches for evaluating pHdependent DDIs, and extrapolating
clinical DDI study results with drug
classes of ARAs.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Evaluation of Gastric pH-Dependent
Drug Interactions With Acid-Reducing
Agents: Study Design, Data Analysis,
and Clinical Implications.’’ 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. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information for submissions of
investigational new drug applications,
new drug applications, and biologic
license applications in 21 CFR parts
312, 314, and 601 have been approved
under OMB control numbers 0910–
0014; 0910–0001; and 0910–0338,
respectively. In addition, the
submission of prescription drug labeling
under 21 CFR 201.56 and 201.57 has
been approved under OMB control
number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
khammond on DSKJM1Z7X2PROD with NOTICES4
Dated: November 25, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26510 Filed 11–30–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0076]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
AGENCY:
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
31, 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 0910–0303. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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77223
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 (21
CFR 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
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
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01DEN1
77224
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
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).
In the Federal Register of August 13,
2020 (85 FR 49381), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
but was not responsive to the
information collection topics solicited.
We estimate the burden of this
collection of information as follows:
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
Number of
record per
recordkeepers
§ 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
21 CFR section
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: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26487 Filed 11–30–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES4
Total annual
records
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Panel; Review of NIGMS SCORE
Applications.
Date: December 17, 2020.
Time: 4:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (Video Meeting).
Contact Person: John J. Laffan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, (301) 594–2773, laffanjo@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: November 24, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–26431 Filed 11–30–20; 8:45 am]
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Name of Committee: National Institute of
General Medical Sciences Special Emphasis
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Microbiome
and Aging 1.
Date: January 7, 2021.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Bita Nakhai, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Bldg., 2C212,
7201 Wisconsin Avenue, Bethesda, MD
20892, (301) 402–7701, nakhaib@nia.nih.gov.
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]]>Agencies
[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77223-77224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0076]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Records;
Electronic Signatures
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 31, 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 0910-0303. 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, 10A-12M, 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.
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 (21 CFR 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 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
[[Page 77224]]
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).
In the Federal Register of August 13, 2020 (85 FR 49381), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was not
responsive to the information collection topics solicited.
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
21 CFR section Number of record per Total annual burden 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: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26487 Filed 11-30-20; 8:45 am]
BILLING CODE 4164-01-P
