Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Signatures, 56035-56036 [2017-25453]
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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
guidance specifies the circumstances
under which packages and homogenous
cases of product that are not labeled
with a product identifier and that are in
the pharmaceutical distribution supply
chain at the time of the effective date of
the requirements of section 582 of the
FD&C Act shall be exempted from
certain requirements of section 582, it
will have binding effect upon
finalization.
II. Electronic Access
Persons with access to the internet
may obtain the guidance document at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.
fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25457 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
Electronic Records; Electronic
Signatures
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
Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by December
27, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 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, 301–796–7729, PRAStaff@
fda.hhs.gov.
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.
DATES:
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:
OMB Control Number 0910–0303—
Extension
This information collection supports
FDA regulations; specifically, in part 11
(21 CFR part 11), which sets forth
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
FDA electronically provided the Agency
has stated its ability to accept the
records electronically in an Agencyestablished public docket and that the
other requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require the following standard operating
procedures to assure appropriate use of,
and precautions for, systems using
56035
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 in writing to FDA 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. The Agency anticipates 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.
In the Federal Register of June 19,
2017 (82 FR 27838), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received in response to the
information collection topics solicited
in the notice. However, one comment
was received regarding a related Agency
draft guidance entitled, ‘‘Use of
Electronic Records and Electronic
Signatures in Clinical Investigations
Under 21 CFR part 11—Questions and
Answers,’’ and the comment has been
directed to the appropriate Agency
components for consideration.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
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.
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27NON1
56036
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
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.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25453 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4562]
Safety Assessment for Investigational
New Drug Safety Reporting; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the public workshop
entitled ‘‘Safety Assessment for IND
Safety Reporting.’’ Convened by the
Duke-Robert J. Margolis, MD, Center for
Health Policy at Duke University and
supported by a cooperative agreement
with FDA, the purpose of the public
workshop is to bring the stakeholder
community together to discuss a variety
of topics related to ‘‘Safety Assessment
for Investigational New Drug (IND)
Safety Reporting.’’ This public
workshop is organized in response to
public comments received to Docket No.
FDA–2015–D–4562 for the draft
guidance ‘‘Safety Assessment for IND
Safety Reporting’’ issued in December
2015 requesting a public meeting to
discuss the draft guidance and its
implications. The public workshop is
intended to engage external
stakeholders in discussions related to
finalizing the draft guidance entitled
‘‘Safety Assessment for IND Safety
Reporting.’’
I. Background
The IND safety reporting requirements
for human drugs and biological
products being studied under an IND
are stated in § 312.32 (21 CFR 312.32).
In 2012, FDA published final guidance
for industry and investigators regarding
implementation of these requirements
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies.1 ’’ During
the evaluation of comments to the draft
guidance for industry and investigators
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies’’ (Docket
No. FDA–2010–D–0482) and at meetings
with stakeholders, FDA identified the
need for additional guidance on IND
safety reporting. The draft guidance for
industry entitled ‘‘Safety Assessment for
IND Safety Reporting’’ was issued in
December 2015 2 as a follow-on to the
guidance for industry and investigators
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies’’ and
provides recommendations for how
sponsors of INDs can identify and
evaluate important safety information
The public workshop will be
held on January 11, 2018, from 9 a.m.
to 4 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
1 Available at: https://www.fda.gov/downloads/
Drugs/Guidances/UCM227351.pdf.
2 https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM477584.pdf.
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The public workshop will
be held at the Conference Center at 1777
F Street NW., Washington, DC 20006.
For additional travel and hotel
information, please refer to the
following Web site: https://
healthpolicy.duke.edu/events/fda-indsafety-reporting-meeting. There will also
be a live webcast for those unable to
attend the meeting in person (see
Streaming Webcast of Public
Workshop).
FOR FURTHER INFORMATION CONTACT:
Lauren Wedlake, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6362,
Silver Spring, MD 20993, 301–796–
2728, Lauren.Wedlake@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
DATES:
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that must be submitted to FDA and all
participating investigators under the
IND safety reporting regulations at
§ 312.32. The focus of this draft
guidance is on safety information that is
only interpretable in the aggregate and
therefore, this guidance is most
applicable to late-stage studies and drug
development programs that have
multiple studies. This guidance
contains recommendations on the
following matters that are most relevant
to sponsors’ review of aggregate data for
IND safety reporting: (1) The entity that
reviews aggregate data, (2) methods for
aggregate analyses of safety data, (3)
maintaining trial integrity while
reviewing unblinded data, and (4)
reporting criteria. This guidance also
contains recommendations regarding
the development of a plan for safety
surveillance, and includes
considerations and recommendations.
Timely reporting of meaningful safety
information allows FDA to consider
whether any changes in study conduct
should be made beyond those initiated
by the sponsor and allows investigators
to make any needed changes to protect
subjects. Simply reporting all serious
adverse events, however, including
those where there is little reason to
consider them suspected adverse
reactions (suspected adverse reactions
being those with a reasonable possibility
of having been caused by the drug), does
not serve this purpose because it may
obscure safety information that is
relevant to the investigational drug.
Sponsors’ effective processes for a
systematic approach to safety
surveillance, coupled with IND safety
reporting of suspected adverse reactions
to FDA and all participating
investigators (and subsequent reporting
to involved institutional review boards),
allows all parties to focus on important
safety issues and to take actions to
minimize the risks of participation in a
clinical trial. Sponsors are encouraged
to have internal processes for governing
the safety surveillance and safety
reporting for their development
programs. Such process may include
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56035-56036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25453]
-----------------------------------------------------------------------
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 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: Fax written comments on the collection of information by
December 27, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 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, 301-796-7729,
PRAStaff@fda.hhs.gov.
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
OMB Control Number 0910-0303--Extension
This information collection supports FDA regulations; specifically,
in part 11 (21 CFR part 11), which sets forth 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 FDA electronically provided the Agency has stated its 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 part 11 (Sec. Sec. 11.10, 11.30,
11.50, and 11.300) require the following standard operating procedures
to assure 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 in writing to FDA
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. The
Agency anticipates 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.
In the Federal Register of June 19, 2017 (82 FR 27838), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the information collection topics solicited in the
notice. However, one comment was received regarding a related Agency
draft guidance entitled, ``Use of Electronic Records and Electronic
Signatures in Clinical Investigations Under 21 CFR part 11--Questions
and Answers,'' and the comment has been directed to the appropriate
Agency components for consideration.
We therefore estimate the burden of this collection of information
as follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[[Page 56036]]
Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
11.10........................... 2,500 1 2,500 20 50,000
11.30........................... 2,500 1 2,500 20 50,000
11.50........................... 4,500 1 4,500 20 90,000
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.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25453 Filed 11-24-17; 8:45 am]
BILLING CODE 4164-01-P
