Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures, 17551-17552 [2014-06918]
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Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Notices
record’’ will now be kept by FDA.
However, the recordkeeping
requirements have not changed for firms
that submit reports of corrections and
removals under part 806. The
predefined data elements of the
electronic 806 report will inherently
enhance the consistency of submission
data by ensuring complete reporting,
thus minimizing the need to solicit
missing data.
(Comment 6) The comments request
the release of the data fields and
proposed online support information for
reporters to review and provide
comments.
(Response) Screen captures of the data
fields are available in the public docket
(https://www.regulations.gov, in Docket
No. FDA–2013–N–0723). The online
support information is available as
follows:
• https://www.fda.gov/forindustry/
electronicsubmissionsgateway/ for
information and support for the ESG,
including information about setting up
a WebTrader account;
• ESGHelpDesk@fda.hhs.gov is the
email address for getting technical help
with submissions;
• https://www.fda.gov/ForIndustry/
FDAeSubmitter/ucm193862.htm
provides tutorials for navigation and use
of the eSubmitter application; and
• https://www.fda.gov/Safety/Recalls/
IndustryGuidance/ucm129334.htm
provides a list of ORA District and
Headquarters Recall Coordinators.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity (21 CFR part)
Electronic process setup (one time) ....................
Submission of corrections and removals (part
806) ..................................................................
1 There
2 Totals
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
hours 2
Total operating
and
maintenance
costs
1,022
1
1,022
9.25
9,454
$30,660
1,033
1
1,033
10
10,330
........................
are no capital costs associated with this collection of information.
may not sum due to rounding.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity (21 CFR part)
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Records of corrections and removals (part 806) .................
93
1
93
10
930
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
FDA’s estimate of the reporting and
recordkeeping burden is based on our
experience with this program and
similar programs that utilize the ESG.
For respondents who use the electronic
process, the operating and maintenance
costs associated with this information
collection are approximately $30 per
year to purchase a digital verification
certificate (certificate must be valid for
1 to 3 years). This burden may be
minimized if the respondent has already
purchased a verification certificate for
other electronic submissions to FDA.
However, FDA is assuming that all
respondents who submit corrections
and removals using the electronic
process will be establishing a new
WebTrader account and purchasing a
digital verification certificate.
Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06917 Filed 3–27–14; 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; Proposed Collection;
Comment Request; Electronic
Records; Electronic Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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.
SUMMARY:
PO 00000
Frm 00058
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Submit either written or
electronic comments on the collection
of information by May 27, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
DATES:
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17552
Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Notices
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 listed 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—(OMB Control Number
0910–0303)—Extension
FDA regulations in part 11 (21 CFR
part 11) provide 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 (§§ 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)
§ 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.
FDA estimates 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—General Requirements ..........................................
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
records per
recordkeeper
Total annual
records
11.10—Controls for closed systems ....................................
11.30—Controls for open systems ......................................
11.50—Signature manifestations .........................................
11.300—Controls for identification codes/passwords ..........
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: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06918 Filed 3–27–14; 8:45 am]
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
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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: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
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]]>Agencies
[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17551-17552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06918]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 written or electronic comments on the collection
of information by May 27, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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
[[Page 17552]]
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 listed 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--(OMB Control Number 0910-
0303)--Extension
FDA regulations in part 11 (21 CFR part 11) provide 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.
FDA estimates 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.100--General Requirements....................................... 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 records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
11.10--Controls for closed 2,500 1 2,500 20 50,000
systems........................
11.30--Controls for open systems 2,500 1 2,500 20 50,000
11.50--Signature manifestations. 4,500 1 4,500 20 90,000
11.300--Controls for 4,500 1 4,500 20 90,000
identification codes/passwords.
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Total....................... .............. .............. .............. .............. 280,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06918 Filed 3-27-14; 8:45 am]
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