Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures, 16017-16018 [E8-6055]
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
implementing direct notices and
parental consent mechanisms will
account for the remaining 300 hours.
Website operators that have
previously created or adjusted their sites
to comply with the Rule will incur no
further burden associated with the Rule,
unless they opt to change their policies
and information collection in ways that
will further invoke the Rule’s
provisions. Moreover, staff believes that
existing COPPA-compliant operators
who introduce additional sites beyond
those they already have created will
incur minimal, if any, incremental PRA
burden. This is because such operators
already have been through the start-up
phase and can carry over the results of
that to the new sites they create.
(b) Voluntary Reporting Requirements
for Safe Harbor Participants: 100 hours
(rounded to the nearest hundred)
Operators can comply with the Rule
by meeting the terms of industry selfregulatory guidelines that the
Commission approves after notice and
comment.3 While the submission of
industry self-regulatory guidelines to
the agency is voluntary, the Rule
includes specific reporting requirements
that all safe harbor applicants must
provide to receive Commission
approval. Staff retains its estimate that
it would require, on average, 265 hours
per new safe harbor program applicant
to prepare and submit its safe harbor
proposal in accordance with Section
312.12(c) of the Rule. Industry sources
have confirmed that this estimate is
reasonable and advised that all of this
time would be attributable to the efforts
of lawyers. Given that several safe
harbor programs are already available to
website operators, FTC staff believes
that it is unlikely that more than one
additional safe harbor applicant will
submit a request within the next three
years of PRA clearance sought. Thus,
annualized burden attributable to this
requirement would be approximately 85
hours per year (260 hours ÷ 3 years) or,
roughly, 100 hours. Staff believes that
most of the records submitted with a
safe harbor request would be those that
these entities have kept in the ordinary
course of business, and that any
incremental effort associated with
maintaining the results of independent
assessments or other records under
Section 312.10(d)(3) also would be in
the normal course of business. In
accordance with the regulations
implementing the PRA, the burden
3 See Section 312.10(c). Approved self-regulatory
guidelines can be found on the FTC’s website at
https://www.ftc.gov/privacy/privacyinitiatives/
childrens_shp.html.
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18:52 Mar 25, 2008
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estimate excludes effort expended for
these activities. 5 CFR 1320.3(b)(2).
Accordingly, FTC staff estimates that
total burden per year for disclosure
requirements affecting new web entrants
and reporting requirements for safe
harbor applications would be
approximately 2,000 hours, rounded to
the nearest thousand.
Labor costs: Labor costs are derived
by applying appropriate hourly cost
figures to the burden hours described
above. Staff conservatively assumes
hourly rates of $150 and $35,
respectively, for lawyers or similar
professionals and computer
programmers.4 Based on these inputs,
staff further estimates that associated
annual labor costs for new entrants
would be $235,000 [(1,500 hours x $150
per hour for legal) + (300 hours x $35
per hour for computer programmers)]
and $15,000 for safe harbor applicants
(100 hours per year x $150 per hour), for
a total labor cost of $250,000.
Non-labor costs: Because websites
will already be equipped with the
computer equipment and software
necessary to comply with the Rule’s
notice requirements, the sole costs
incurred by the websites are the
aforementioned estimated labor costs.
Similarly, industry members should
already have in place the means to
retain and store the records that must be
kept under the Rule’s safe harbor
recordkeeping provisions, because they
are likely to have been keeping these
records independent of the Rule.
William J. Blumenthal
General Counsel
[FR Doc. E8–6211 Filed 3–25–08: 8:45 am]
BILLING CODE 6750–01–S
4 FTC staff estimates average legal costs at $150
per hour, which is roughly midway between Bureau
of Labor Statistics (BLS) mean hourly wages shown
for attorneys (approximately $55) in the most recent
whole-year data available online (2006) and what
staff believes may more generally reflect hourly
attorney costs ($250) associated with Commission
information collection activities. The $35 estimate
for computer programmers is also conservatively
based on the most recent whole-year data available
online from the BLS (2006 National Compensation
Survey and 2006 Occupational Employment and
Wage Statistics).
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16017
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0168]
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
information collection provisions
relating to FDA’s electronic records and
electronic signatures.
DATES: Submit written or electronic
comments on the collection of
information by May 27, 2008.
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:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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
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
E:\FR\FM\26MRN1.SGM
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16018
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
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
The FDA regulations in 21 CFR part
11 (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 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 will be 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 BURDEN1
No. of
Respondents
21 CFR Section
11.100
1 There
Annual Frequency
per Response
4,500
Total Annual
Responses
1
Hours per
Response
4,500
Total Hours
1
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total 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
pwalker on PROD1PC71 with NOTICES
1 There
280,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6055 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0169]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16017-16018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6055]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0168]
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 information collection
provisions relating to FDA's electronic records and electronic
signatures.
DATES: Submit written or electronic comments on the collection of
information by May 27, 2008.
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: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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 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
[[Page 16018]]
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
The FDA regulations in 21 CFR part 11 (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 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 will be 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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response 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.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6055 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
