[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Rules and Regulations]
[Pages 14796-14797]
[FR Doc No: 2011-6300]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-24145; Directorate Identifier 2006-NE-06-AD;
Amendment 39-16638; AD 2011-07-01]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF6-45 and
CF6-50 Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
for General Electric Company (GE) CF6-45 and CF6-50 series turbofan
engines. That AD currently requires replacing certain forward and aft
centerbodies of the long fixed core exhaust nozzle (LFCEN) assembly.
This AD adds certain new forward and aft centerbody part numbers (P/Ns)
to the list requiring replacement. This AD was prompted by the
discovery of more LFCEN forward and aft centerbody P/Ns that require
replacement. We are issuing this AD to prevent the forward and aft
centerbody of the LFCEN assembly from separating from the engine,
causing damage to the engine, and damage to the airplane.

DATES: This AD is effective April 22, 2011.

ADDRESSES: For service information identified in this AD, contact GE-
Aviation M/D Rm. 285, One Neumann Way, Cincinnati, OH 45215, telephone
513-552-3272; e-mail<EMAIL_ADDRESS>You may review copies of the
referenced service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call 781-
238-7125.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tomasz Rakowski, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede airworthiness directive (AD) 2009-04-17, Amendment
39-15823 (74 FR 8735, February 26, 2009). That AD applies to the
specified products. The NPRM published in the Federal Register on
January 4, 2011 (76 FR 292). That NPRM proposed to add forward
centerbody P/Ns 9076M28G05, G06, and G08, P/Ns 9076M82G01 and G03, and
aft centerbody P/Ns 9076M46G02 and G04 to the P/Ns in AD 2009-04-17
that are required to be removed from service.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
and the FAA's response to the comment.

Request

    One commenter, Boeing Commercial Airplanes, pointed out that the
McDonnell Douglas airplanes affected by the proposed AD should be
listed out as DC-10-15, DC-10-30, DC-10-30F, KC-10, KDC-10, and MD-10-
30F. The commenter stated that the proposed AD only listed these
airplanes as a series.
    We agree. We revised this AD as requested, except we listed KC-10
as KC-10A as it appears in the Type Certificate Data Sheet.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously.

Costs of Compliance

    We estimate that this AD will affect 383 GE CF6-45 and CF6-50
series turbofan engines installed on airplanes of U.S. registry. We
also estimate that it will take about 44 work hours per engine to
perform the actions required by this AD, and that the average labor
rate is $85 per work-hour. Required parts will cost about $11,000 per
engine. Based on these figures, we estimate the total cost of this AD
to U.S. operators to be $5,645,420.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on

products identified in this rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2009-04-17, Amendment 39-15823 (74 FR 8735; February 26, 2009), and
adding the following new AD:

2011-07-01 General Electric Company: Amendment 39-16638 ; Docket No.
FAA-2006-24145; Directorate Identifier 2006-NE-06-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective April 22,
2011.

Affected ADs

    (b) This AD supersedes AD 2009-04-17, Amendment 39-15823.

Applicability

    (c) This AD applies to the following engines with a long fixed
core exhaust nozzle (LFCEN) assembly forward centerbody, part number
(P/N) 1313M55G01 or G02, P/N 9076M28G05, G06, G08, G09, or G10, P/N
9076M82G01 or G03, and aft centerbody P/N 1313M56G01, or P/N
9076M46G02, G04, or G05, installed in:
    (1) General Electric Company (GE) CF6-45A, CF6-45A2, CF6-50A,
CF6-50C, CF6-50CA, CF6-50C1, CF6-50C2, CF6-50C2B, CF6-50C2D, CF6-
50E, CF6-50E1, CF6-50E2, and CF6-50E2B turbofan engines, including
engines marked on the engine data plate as CF6-50C2-F and CF6-50C2-
R.
    (2) These engines are installed on, but not limited to, Airbus
A300 series, Boeing 747-200B, 747-200C, 747-200F, 747-300 and 747SR,
McDonnell Douglas DC-10-15, DC-10-30, DC-10-30F (KC-10A, KDC-10),
and MD-10-30F airplanes.

Unsafe Condition

    (d) This AD was prompted by the discovery of more LFCEN forward
and aft centerbody P/Ns that require replacement. We are issuing
this AD to prevent the forward and aft centerbody of the LFCEN
assembly from separating from the engine, causing damage to the
engine, and damage to the airplane.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.
    (1) Within 18 months after the effective date of this AD,
replace forward centerbody, P/N 1313M55G01 and G02, P/N 9076M28G05,
G06, G08, G09, and G10, P/N 9076M82G01 and G03, and aft centerbody
P/N 1313M56G01, P/N 9076M46G02, G04, and G05 with a forward and aft
centerbody that has been modified using the Accomplishment
Instructions, Section 3, of GE Service Bulletin (SB) No. CF6-50 S/B
78-0244, Revision 1, dated March 13, 2008, CF6-50 S/B 78-0244, dated
July 30, 2007, or CF6-50 S/B 78-0242, dated September 26, 2005.

Centerbody Installation Prohibition

    (2) After 18 months from the effective date of this AD, do not
install any engine with forward centerbody, P/N 1313M55G01 or G02,
P/N 9076M28G05, G06, G08, G09, or G10, P/N 9076M82G01 or G03, or aft
centerbody P/N 1313M56G01, P/N 9076M46G02, G04, or G05 on any
airplane.

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Engine Certification Office, FAA, may approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (g) For more information about this AD, contact Tomasz Rakowski,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>    (h) For service information identified in this AD, contact GE-
Aviation M/D Rm. 285, One Neumann Way, Cincinnati, OH 45215,
telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>You may review
copies of the referenced service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on March 14, 2011.
Peter A. White,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-6300 Filed 3-17-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 61 (Thursday, March 29, 2012)]
[Rules and Regulations]
[Pages 18922-18923]
[FR Doc No: 2012-7563]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0818; FRL-9654-1]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Determinations of Clean Data for the 2006 24-Hour Fine
Particulate Standard for the Harrisburg-Lebanon-Carlisle-York,
Allentown, Johnstown, and Lancaster Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is making a final determination regarding the Harrisburg-
Lebanon-Carlisle-York, Allentown, Johnstown, and Lancaster
nonattainment areas (hereafter referred to as ``Areas'') for the 24-
hour 2006 fine particulate matter (PM2.5) national ambient
air quality standard (NAAQS). EPA is determining that the Areas have
clean data for the 24-hour 2006 PM2.5 NAAQS. These
determinations are based upon complete, quality-assured, quality-
controlled, and certified ambient air monitoring data showing that
these Areas have monitored attainment of the 24-hour 2006
PM2.5 NAAQS based on the 2008-2010 data in EPA's Air Quality
System (AQS) database. EPA's determinations relieve these Areas from
the requirements to submit an attainment demonstration, associated
reasonably available control measures, a reasonable further progress
plan, contingency measures, and other planning State Implementation
Plans (SIPs) related to attainment of the standard for so long as these
Areas continue to meet the 24-hour 2006 PM2.5 NAAQS.

DATES: Effective Date: This final rule is effective on April 30, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2011-0818. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. What action is EPA taking?
II. What is the effect of this action?
III. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is making final determinations that the Harrisburg-Lebanon-
Carlisle-York, Allentown, Johnstown, and Lancaster nonattainment areas
have clean data for the 24-hour 2006 PM2.5 NAAQS. These
determinations are based upon complete, quality-assured, quality-
controlled, and certified ambient air monitoring data showing that
these Areas have monitored attainment of the 2006 PM2.5
NAAQS based on the 2008-2010 monitoring data.
    On January 20, 2012 (77 FR 2941), EPA proposed determinations of
clean data for the Harrisburg-Lebanon-Carlisle-York, Allentown,
Johnstown, and Lancaster nonattainment areas. A discussion of the
rationale behind these determinations and the effect of these
determinations were included in the notice of proposed rulemaking. EPA
received no comments on this notice of proposed rulemaking.

II. What is the effect of this action?

    Under the provisions of EPA's PM2.5 implementation rule
(See 40 CFR 51.1004(c)), the requirements for the Harrisburg-Lebanon-
Carlisle-York, Allentown, Johnstown, and Lancaster nonattainment areas
to submit an attainment demonstration and associated reasonably
available control measures (including reasonably available control
technology), a reasonable further progress plan, contingency measures,
and any other planning SIPs related to attainment of the 2006
PM2.5 NAAQS are suspended for so long as the Areas continue
to meet the 24-hour 2006 PM2.5 NAAQS. If EPA subsequently
determines that these Areas violate the 24-hour 2006 PM2.5

NAAQS, the basis for the suspension of the specific requirements, set
forth at 40 CFR 51.1004(c), would no longer exist and these Areas would
thereafter have to address the pertinent requirements.
    This action does not constitute a redesignation of these Areas to
attainment for the 24-hour 2006 PM2.5 NAAQS under section
107(d)(3) of the Clean Air Act (CAA). Further, this action does not
involve approving maintenance plans for these Areas as required under
section 175A of the CAA, nor does it find that the Areas have met all
other requirements for redesignation. Even after these determinations
of attainment by EPA, the designation status of these Areas is
nonattainment for the 24-hour 2006 PM2.5 NAAQS until such
time as EPA determines that the Areas meet the CAA requirements for
redesignation to attainment and takes action to redesignate these
Areas.

III. Statutory and Executive Order Reviews

A. General Requirements

    This action makes determinations of attainment based on air
quality, and will result in the suspension of certain Federal
requirements, and will not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 29, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    These clean data determinations for the 24-hour 2006
PM2.5 NAAQS for the Harrisburg-Lebanon-Carlisle-York,
Allentown, Johnstown, and Lancaster nonattainment areas may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: March 19, 2012.
W.C. Early,
Acting Regional Administrator, Region III.

    40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

     Authority:  42 U.S.C. 7401 et seq.

Subpart NN--Pennsylvania

0
2. In Sec.  52.2059, paragraph (e) is added to read as follows:

Sec.  52.2059  Control strategy: Particulate matter.

* * * * *
    (e) Determination of Clean Data. EPA has determined, as of March
29, 2012, that based on 2008 to 2010 ambient air quality data, the
Harrisburg-Lebanon-Carlisle-York, Allentown, Johnstown, and Lancaster
nonattainment areas have attained the 24-hour 2006 PM2.5
NAAQS. These determinations, in accordance with 40 CFR 51.1004(c),
suspend the requirements for these areas to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and other
planning SIPs related to attainment of the standard for as long as
these areas continue to meet the 24-hour 2006 PM2.5 NAAQS.

[FR Doc. 2012-7563 Filed 3-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64441-64443]
[FR Doc No: 2023-20233]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3743]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Records; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection applicable to the
electronic record signature provisions found in Agency regulations.

DATES: Either electronic or written comments on the collection of
information must be submitted by November 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2023-N-3743 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Good Laboratory Practice
Requirements for Nonclinical Laboratory Studies.'' 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, 240-
402-7500.
     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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>,
[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 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--Revision

    This information collection supports implementation of statutory
and regulatory authorities that govern criteria for the acceptance of
electronic records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records. Agency
regulations in part 11 (21 CFR part 11), provide for the submission of
records and reports and establish that information may be submitted to
FDA 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 regulations apply
to records in electronic form that are created, modified, maintained,
archived, retrieved, or transmitted, under any records requirements set
forth in Agency regulations and to electronic records submitted under
requirements of the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act, even if such records are not specifically
identified in Agency regulations.
    Regulations in part 11, subpart B (Sec. Sec.  11.10 through 11.70)
and) require the establishment of standard operating procedures to
ensure appropriate use of and precautions for systems using electronic
records and signatures, including the following: (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;
and (3) Sec.  11.50 specifies procedures and controls for persons who
use electronic signatures.
    Regulations in subpart C (Sec. Sec.  11.100 through 11.300) require
specific controls to ensure the security and integrity of electronic
signatures based upon use of identification codes in combination with
passwords.
    On March 3, 2023 (88 FR 13018), we revised the regulations. Before
using an electronic signature in an electronic record required by FDA,
a person must submit a letter of nonrepudiation to FDA (Sec.
11.100(c)). Letters of nonrepudiation are required under Sec.
11.100(c)(1) to certify that a person's electronic signatures are
intended to be the legally binding equivalent of traditional
handwritten signatures. The regulations were amended to update the
address for submission of a certification in paper form and to provide
an option for electronic submission. The regulations were also amended
to communicate that information on where to submit the certification
may be found on FDA's website, currently available at: https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement.
    We estimate the burden of the information collection 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; submission of nonrepudiation letters................           5,000                1            5,000                1            5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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; controls for                 2,500               1           2,500              20          50,000
 closed systems.................
Sec.   11.30; controls for open            2,500               1           2,500              20          50,000
 systems........................
Sec.   11.50; signature                    5,000               1           5,000              20         100,000
 manifestations.................
Sec.   11.300; controls for                5,000               1           5,000              20         100,000
 identifications and passwords..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         300,000
----------------------------------------------------------------------------------------------------------------
\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 increased our estimated burden. We
assume 5,000 nonrepudiation letters will be submitted annually. We
arrived at this figure by looking at the average number of
nonrepudiation letters received through March 2023. We further assume
that half of the estimated respondents will establish controls for open
systems and half will establish controls for closed systems. Finally,
we assume all respondents will establish controls for the remaining
technical specifications required by the regulations.

    Dated: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20233 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]
[Page 39610-39611]
[DOCID:fr09jy10-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62429; File No. SR-FINRA-2010-031]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Amending Financial Industry Regulatory Authority,
Inc. Online Form NMA

July 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 24, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as ``constituting a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule'' under Section
19(b)(3)(A)(i) of the Act \3\ and Rule 19b-4(f)(1) thereunder,\4\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend online Form NMA, the standardized
membership application form applicants must file pursuant to NASD Rule
1013 (New Member Application and Interview) as part of their new
membership application. The proposed change would amend Form NMA's
hyperlink reference to SEC Form D (Notice of Exempt Offering of
Securities) from ``high net worth,'' to ``accredited investor,'' the
term used in SEC Form D.
    The proposed rule change does not propose amendments to existing
rule text.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Form NMA is the standardized online membership application form
applicants must file pursuant to NASD Rule 1013 (New Member Application
and Interview) as part of their new membership application. Form NMA
assists applicants by identifying the information and supporting
documentation required by Rule 1013. To that end, Form NMA Section I,
Question 8a requires an applicant to identify (by indicating all that
apply) the following types of customers the applicant will service: (1)
Retail excluding high net worth; (2) high net worth; (3) institutional
excluding high net worth; or (4) other (as described by the applicant).
Form NMA does not provide a definition of a ``high net worth'' retail
or institutional customer; rather, the form provides guidance to
applicants responding to the question by providing a hyperlink for the
term ``high net worth'' to SEC Form D (Notice of Exempt Offering of
Securities), which references the term ``accredited investor'' as
defined in Rule 501(a) of the Securities Act of 1933 (``Securities
Act'').\5\
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    \5\ 17 CFR 230.501(a). Securities Act Rule 501(a) defines the
term ``accredited investor'' to mean any person who comes within
certain categories, as specified in the definition, at the time of
the sale of the securities to that person. Those categories include,
among others, institutions, such as banks, insurance companies, and
employee benefit plans; trusts with total assets in excess of
$5,000,000; and any natural persons with either an individual income
for the past two years over $200,000 (or joint income over $300,000
if married) or an individual net worth (or joint net worth if
married) exceeding $1,000,000.
---------------------------------------------------------------------------

    The proposed rule change will replace the hyperlink reference
``high net worth'' with ``accredited investor,'' thereby conforming the
terminology used in Question I, Section 8a to SEC Form D.\6\
---------------------------------------------------------------------------

    \6\ The proposed rule change also will update the nonworking
hyperlink address to SEC Form D with the current hyperlink address,
http://www.sec.gov/about/forms/formd.pdf.
---------------------------------------------------------------------------

    The effective date will be the date of filing; FINRA anticipates
implementing the proposed rule change as part of a software release
scheduled for July 31, 2010.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\7\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. The proposed rule change is consistent with the
provisions stated above, as it updates a hyperlink reference in online
Form NMA, providing greater clarity to applicants for FINRA membership.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f)(1) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-031 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2010-031. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2010-031
and should be submitted on or before July 30, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Elizabeth M. Murphy,
Secretary.
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    \10\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2010-16685 Filed 7-8-10; 8:45 am]
BILLING CODE 8010-01-P