[Federal Register Volume 84, Number 158 (Thursday, August 15, 2019)]
[Unknown Section]
[Pages 41599-41602]
[FR Doc No: 2019-17504]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0117; Product Identifier 2018-NM-169-AD; Amendment
39-19696; AD 2019-15-03]
RIN 2120-AA64

Airworthiness Directives; 328 Support Services GmbH (Type
Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild
Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
328 Support Services GmbH Model 328-100 airplanes. This AD was prompted
by a report indicating that undetected cracks may develop at the roll
spoiler bearing arms. This AD requires a one-time non-destructive test
(NDT) inspection for cracks in the roll spoiler bearing arms and, if
necessary, corrective actions. The agency is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective September 19, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
19, 2019.

ADDRESSES: For service information identified in this final rule,
contact 328 Support Services GmbH, Global Support Center, P.O. Box
1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153
88111 6666; fax +49 8153 88111 6565; email [email protected];
internet http://www.328support.de. You may view this service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0117.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0117; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is 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: Todd Thompson, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all 328 Support
Services GmbH Model 328-100 airplanes. The NPRM published in the
Federal Register on March 8, 2019 (84 FR 8482). The NPRM was prompted
by a report indicating that undetected cracks may develop at the roll
spoiler bearing arms. The NPRM proposed to require a one-time NDT
inspection for cracks in the roll spoiler bearing arms and, if
necessary, corrective actions.
    The FAA is issuing this AD to address cracks at the roll spoiler
bearing arms, which, if not detected and corrected, could lead to a
roll spoiler becoming unresponsive to flight crew control inputs,
possibly resulting in loss of control of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2018-0254R1, dated June 4, 2019 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all 328 Support

Services GmbH Model 328-100 airplanes. The MCAI states:

    Dornier 328 Maintenance Review Board Report provides
instructions for a detailed inspection for the roll spoilers,
including the bearing arms, by eddy current [EC] method. It was
reported that whilst performing Maintenance Planning Document Task
57-71-03-02-01, referring to Non-Destructive Test (NDT) Manual task
57-71-03-318-000-AA0, the stacking of 6 parts at the bearing arm No.
3 prevents detection of cracks with the given EC test settings. The
NDT results are distorted by geometric features such as part edges
and fastener installations. Furthermore, the access to certain areas
is limited for the suggested NDT probe for geometrical reasons. The
result of the technical investigation identified that undetected
cracks may develop at the roll spoiler bearing arms, leading to a
broken (disconnected) bearing arm No. 3, where the actuator is
connected.
    This condition, if not detected and corrected, could lead to a
roll spoiler becoming unresponsive to flight crew control inputs,
possibly resulting in loss of control of the aeroplane.
    To address this potential unsafe condition, 328 SSG published
the ASB [328 Support Services Alert Service Bulletin ASB-328-57-043,
dated September 21, 2018] to provide appropriate inspection
instructions.
    For the reasons described above, EASA issued AD 2018-0254 to
require a one-time NDT inspection of the affected parts and,
depending on findings, accomplishment of applicable corrective
action(s).
    Since that [EASA] AD was issued, it was noted that an error had
been made in the compliance times, creating an inconsistency with
those in the ASB. This [EASA] AD is revised to correct those errors.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0117.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Requests To Correct Compliance Time

    The commenters, David Davidson and David Moreno, each requested
that the compliance time for accomplishing the NDT inspection specified
in paragraph (h) of the proposed AD be revised to require the
inspection within 2,500 flight hours (FH) after the effective date of
the proposed AD instead of within 2,500 flight cycles (FC) after the
effective date of the proposed AD. The commenters noted that a
compliance time counted in FC conflicts with the compliance time
specified in 328 Support Services Alert Service Bulletin ASB-328-57-
043, dated September 21, 2018. The commenters went on to point out that
using a compliance time counted in FH aligns with the regularly
scheduled A5 maintenance check.
    The FAA agrees with the commenters' requests to revise the
specified compliance time from FC to FH. Since the agency issued the
NPRM, EASA issued 2018-0254R1, dated June 4, 2019, to correct the
identified error in the specified compliance time. The FAA has
discussed this change with EASA and determined that using a FH
compliance time will not adversely affect safety, and will allow the
modification to be performed during regularly scheduled maintenance.
Further, EASA and 328 Support Services GmbH provided data that confirms
that the difference between FH and FC for determining compliance time
is small, and the burden to the operator is minimal as a result of this
change. Therefore, where figure 1 to paragraph (h) of the proposed AD
used the phrase ``within 2,500 FC after the effective date of this
AD,'' the FAA has revised figure 1 to paragraph (h) of this final AD to
state ``within 2,500 FH after the effective date of this AD.''

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule with the change described previously
and minor editorial changes. The agency has determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    The FAA has also determined that these changes will not increase
the economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    328 Support Services has issued Alert Service Bulletin ASB-328-57-
043, dated September 21, 2018. This service information describes
procedures for a one-time NDT inspection for cracks in the roll spoiler
bearing arms. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 27 airplanes of U.S.
registry. The agency estimates the following costs to comply with this
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
8 work-hours x $85 per hour = $680...........................              $0             $680          $18,360
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this AD.

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.
    The FAA is 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has

delegated the authority to issue ADs applicable to transport category
airplanes and associated appliances to the Director of the System
Oversight Division.

Regulatory Findings

    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) Will not affect intrastate aviation in Alaska, and
    (3) 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, Incorporation by
reference, 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 adding the following new airworthiness
directive (AD):

2019-15-03 328 Support Services GmbH (Type Certificate Previously
Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier
Luftfahrt GmbH): Amendment 39-19696; Docket No. FAA-2019-0117;
Product Identifier 2018-NM-169-AD.

(a) Effective Date

    This AD is effective September 19, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to 328 Support Services GmbH (Type Certificate
previously held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH;
Dornier Luftfahrt GmbH) Model 328-100 airplanes, certificated in any
category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by a report indicating that undetected
cracks may develop at the roll spoiler bearing arms. The FAA is
issuing this AD to address cracking at the roll spoiler bearing
arms, which, if not detected and corrected, could lead to a roll
spoiler becoming unresponsive to flight crew control inputs,
possibly resulting in loss of control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definition of Affected Parts

    For the purposes of this AD, an affected part is the bearing arm
of roll spoilers having part number (P/N) 001B577A1200000,
001B577A1200001, 001B577A1200002, 001B577A1200003, 001B577A1200004,
or 001B577A1200005.

(h) Inspection

    Within the compliance time specified in Figure 1 to paragraph
(h) of this AD, as applicable, do a non-destructive test (NDT)
inspection of each affected part, in accordance with the
Accomplishment Instructions of 328 Support Services Alert Service
Bulletin ASB-328-57-043, dated September 21, 2018. The flight cycles
(FC) specified in Figure 1 to paragraph (h) of this AD are the FC
accumulated on the airplane since first flight of the airplane,
unless otherwise specified.
[GRAPHIC] [TIFF OMITTED] TR15AU19.002

(i) Corrective Action

    If any crack is found during any inspection required by
paragraph (h) of this AD: Before further flight, obtain corrective
actions approved by the Manager, International Section, Transport
Standards Branch, FAA; or the European Aviation Safety Agency
(EASA); or 328 Support Services GmbH's EASA Design Organization
Approval (DOA); and accomplish the corrective actions within the
compliance time specified therein. If approved by the DOA, the
approval must include the DOA-authorized signature.

(j) No Reporting Requirement

    Although 328 Support Services Alert Service Bulletin ASB-328-57-
043, dated September 21, 2018, specifies to submit certain
information to the manufacturer, this AD does not include that
requirement.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (l)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or 328 Support
Services GmbH's EASA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0254R1, dated June 4, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2019-0117.
    (2) For more information about this AD, contact Todd Thompson,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) 328 Support Services Alert Service Bulletin ASB-328-57-043,
dated September 21, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact 328
Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231
Wessling, Federal Republic of Germany; telephone +49 8153 88111
6666; fax +49 8153 88111 6565; email [email protected]; internet
http://www.328support.de.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on July 26, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-17504 Filed 8-14-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Rules and Regulations]
[Pages 49524-49526]
[FR Doc No: 2022-16905]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0718; FRL-9935-02-R4]

Air Plan Approval; NC: Inspection and Maintenance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing
approval of a State Implementation Plan (SIP) revision submitted by the
State of North Carolina on December 14, 2020, through the Department of
Environmental Quality (DEQ), Division of Air Quality (DAQ), for the
purpose of removing Lee, Onslow, and Rockingham Counties from

North Carolina's motor vehicle inspection and maintenance (I/M)
program. EPA is approving these changes pursuant to the Clean Air Act
(CAA or Act).

DATES: This rule is effective September 12, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0718. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that, if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9222. Ms. Sheckler can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Overview

    The DAQ submitted a SIP revision on December 14, 2020, seeking to
remove Lee, Onslow, and Rockingham Counties from North Carolina's SIP-
approved I/M program. The DAQ submitted this SIP revision in response
to North Carolina legislation enacted in Session Law 2020-5, House Bill
85, which amended North Carolina General Statute section 143-
215.107A(c) to remove these three counties from the North Carolina I/M
Program.\1\ Specifically, the North Carolina Act requires the
elimination of Lee, Onslow, and Rockingham Counties from the I/M
program and the retention of the I/M program in 19 counties (Alamance,
Buncombe, Cabarrus, Cumberland, Davidson, Durham, Forsyth, Franklin,
Gaston, Guilford, Iredell, Johnston, Lincoln, Mecklenburg, New Hanover,
Randolph, Rowan, Union, and Wake).
---------------------------------------------------------------------------

    \1\ The removal becomes effective the first day of a month that
is sixty days after the State's Secretary of the DEQ certifies to
the State's Revisor of Statutes that EPA approved the SIP revision.
---------------------------------------------------------------------------

    Sections 187(a)(4) and 182(b)(4) of the CAA require the
implementation of an I/M program in certain areas classified as
moderate nonattainment or higher for the ozone or carbon monoxide (CO)
NAAQS.\2\ Lee, Onslow, and Rockingham Counties have never been
designated nonattainment for ozone or CO (or any other NAAQS) and are
currently in attainment for all NAAQS. These three counties were
included in the State's I/M program to provide North Carolina with
emissions credit for the NOX SIP Call obligations. See 67 FR
66056 (October 30, 2002). The NOX SIP Call, issued by EPA in
1998, required some states, including North Carolina, to meet statewide
NOX emission requirements during the ozone season (May 1
through September 30 control period) to reduce the amount of ground
level ozone that is transported across the eastern United States. See
84 FR 8422 (March 8, 2019).
---------------------------------------------------------------------------

    \2\ The I/M program was never a mandatory program pursuant to
the CAA for Lee, Onslow, or Rockingham counties.
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    In a notice of proposed rulemaking (NPRM), published on June 22,
2022, EPA proposed to approve the removal of Lee, Onslow, and
Rockingham Counties from North Carolina's SIP-approved I/M program (and
consequently, the removal of reliance on credits gained from I/M
emissions reductions from Lee, Onslow and Rockingham Counties in the
State's NOX Budget and Allowance Trading Program). See 87 FR
37280. As explained in the June 22, 2022, NPRM, EPA found that the
removal of the I/M program for the Lee, Onslow, and Rockingham Counties
would not impact North Carolina's ability to attain or maintain
compliance with the NAAQS and would not interfere with the State's
obligations under the NOX SIP Call. Comments on the June 22,
2022, NPRM, were due on or before July 22, 2022. EPA did not receive
any adverse comments on the June 22, 2022, NPRM.

II. Final Action

    EPA is finalizing approval of North Carolina's December 14, 2020,
SIP revision. Specifically, EPA is approving the removal of Lee,
Onslow, and Rockingham Counties from the SIP-approved I/M program.
Additionally, EPA finds that North Carolina's removal of the three
counties from the SIP-approved I/M program (and the removal of reliance
on the I/M emissions reductions generated from those counties as part
of the ``credits'' in North Carolina's NOX emissions budget)
will not interfere with the State's obligations under the
NOX SIP Call to meet its Statewide NOX emissions
budget. EPA finds that the approval of this revision will not interfere
with continued attainment or maintenance of any applicable NAAQS, or
with any other applicable requirement of the CAA. EPA also finds that
North Carolina's December 14, 2020, SIP submission satisfies the
requirements of section 110(l) of the CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    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).
    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 October 11, 2022. 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. This action 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 1, 2022.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart II--North Carolina

0
2. In Sec.  52.1770 in paragraph (e), amend the table by adding a new
entry for ``Removal of Lee, Onslow, and Rockingham Counties from North
Carolina's Inspection and Maintenance Program and 110(l) Non-
Interference Demonstration'' at the end to read as follows:

Sec.  52.1770   Identification of plan.

* * * * *
    (e) * * *

                              EPA-Approved North Carolina Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                             State       EPA approval       Federal Register
               Provision                effective date       date               citation            Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Removal of Lee, Onslow, and Rockingham      12/14/2020       8/11/2022  [Insert citation of
 Counties from North Carolina's                                          publication].
 Inspection and Maintenance Program
 and 110(l) Non-Interference
 Demonstration.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-16905 Filed 8-10-22; 8:45 am]
BILLING CODE 6560-50-P


y the Office of the Secretary. These filings are available for review at the Enter the docket number excluding the last three digits in the docket number free at ( 866) 208 3676, or for TTY, contact ( 202) 502   8659.

Docket no. Date filed Presenter or requester Prohibited: 1. RP01   620   000 .................................................................. 2   12   03 Ibtissam Chang 2. EC03   20   000/ 001/ 002 ...................................................... 2   19   03 Ronald L. Leibow Exempt: 1. ER02   2330   001/ 002 ......................................................... 2   7   03 Richard A. Montuori 2. ER02   2330   001/ 002 ......................................................... 2   10   03 Robby Robertson 3. ER02   2330   001/ 002 ......................................................... 2   10   03 Deborah B. Goldberg 4. ER02   2330   001/ 002 ......................................................... 2   10   03 William J. Mauro, Jr 5. ER02   2330   001/ 002 ......................................................... 2   10   03 Mark J. Purple 6. ER02   2330   001/ 002 ......................................................... 2   10   03 Benjamin E. Puritz 7. Project No. 2069   007 ........................................................ 2   12   03 Nan Allen 8. Project No. 2493   006 ........................................................ 2   12   03 D. Robert Lohn 9. CP02   396   000 .................................................................. 2   12   03 Trevor Loveday 10. Project No. 2726   012 ...................................................... 2   13   03 John Blair/ Jennifer Hill 11. CP02   396   000 ................................................................ 2   20   03 Joanne Wachholder 12. Project No. 637   000 ........................................................ 2   20   03 John T. Gangemi Magalie R. Salas, Secretary. [ FR Doc. 03   4846 Filed 2   28   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ OECA   2002   0016; FRL   7456   7]

Agency Information Collection Activities: Submission for OMB Review and Approval; Comment Request; NSPS Subpart Da   Standards of Performance for Electric Utility Steam Generating Units, ICR No. 1053.07, OMB Number 2060   0023 AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: NSPS Subpart Da   Standards of Performance for Electric Utility Steam Generating Units, OMB Control Number 2060   0023, EPA ICR No. 1053.07. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. DATES: Comments must be submitted on or before April 2, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Dan Chadwick, Compliance Assessment and Media Programs Division, Office of Compliance, Mail Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number ( 202) 564   7054; fax number ( 202) 564   0050; email address chadwick. dan@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 20, 2002 ( 67 FR 41981), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA   2002   0016, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566   1514. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by email to docket. oeca@ epa. gov or by mail to EPA Docket Center, Environmental Protection Agency, Mail code: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May VerDate Jan< 31> 2003 19: 53 Feb 28, 2003 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03MRN1. SGM 03MRN1 g ( 2060   0023, EPA ICR No. 1053.07). This is a request to renew an existing approved collection that is scheduled to expire on February 28, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Owners or operators of electric utility steam generating units subject to NSPS Subpart Da must make one time notification of construction/ reconstruction, anticipated and actual startup, initial performance test, physical or operational changes, and demonstration of a continuous monitoring system. They must also submit a report on initial performance test results, monitoring results, and excess emissions. Records must be maintained of startups, shutdowns, malfunctions, periods when the continuous monitoring system is inoperative, and of various fuel combustion and pollutant emission parameters. The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. Performance test reports are needed as these are the Agency's records of a source's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved. The monitoring and excess emissions reports are used for problem identification, as a check on source operation and maintenance, and for compliance determination. The information collected from recordkeeping and reporting requirements are used for targeting inspections, and for other uses in compliance and enforcement programs. Responses to these information collections are deemed to be mandatory, per section 114( a) of the Clean Air Act. The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B   Confidentiality of Business Information ( see 40 CFR part 2; 41 FR 36902, September 1, 1976; amended by 43 FR 4000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979). control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 85 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Owners or operators of electric utility steam generating units subject to Subpart Da. Estimated Number of Respondents: 655. Frequency of Response: Semiannually, quarterly. Estimated Total Annual Hour Burden: 33,553. Estimated Total Annual Cost: $ 19,490,000, includes $ 2,200,000 annualized capital and $ 9,660,000 O& M costs. Changes in the Estimates: There is an increase of 104,947 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an increase in the size of the regulated universe.

Dated: February 19, 2003.

Oscar Morales,

Director, Collection Strategies Division. [ FR Doc. 03   4913 Filed 2   28   03; 8: 45 am]

BILLING CODE 6560   50   P Agency Information Collection Activities: Submission of EPA ICR No. 1893.03 ( OMB No. 2060   0430) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Title: Federal Emission Guidelines For Existing Municipal Solid Waste Landfills ( Small) ( 40 CFR part 62, subpart GGG) ( OMB Control Number 2060   0430; EPA ICR No. 1893.03). The ICR which is abstracted below, describes the nature of the information collection and its expected burden and cost. DATES: Additional comments may be submitted on or before April 2, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: For questions about this ICR, contact Sharie Centilla, Office of Enforcement and Compliance/ Office of Compliance, mail code 2224A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; phone number: ( 202) 564   0697; fax number: ( 202) 564   0009; e mail address: centilla. sharie@ epa. gov. Refer to EPA ICR Number 1893.03. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On November 7, 2002 ( 67 FR 67830) EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for this ICR under Docket ID No. OECA   2002   0022, which is available for public viewing at the Enforcement and Compliance Docket and Information Center ( ECDIC) in the EPA Docket Center ( EPA/ DC), EPA West Building, Room B   102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and VerDate Jan< 31> 2003 19: 53 Feb 28, 2003 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03MRN1. SGM 03MRN1


[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7657-7659]
[FR Doc No: 2015-02749]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74211; File No. SR-BX-2015-008]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX BX, Inc. Relating
to a Typographical Error

February 5, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that, on January 29, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the BX Rulebook at Options Chapter
VI, Section 1 to correct a typographical error in a previous rule
change.
    The Exchange requests that the Commission waive the 30-day
operative delay period contained in Exchange Act Rule 19b-
4(f)(6)(iii).\3\
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    \3\ 17 CFR 240.19b-4(f)(6)(iii).
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwall street.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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. The Exchange 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
    The Exchange is proposing to modify the Exchange's Rulebook at
Chapter VI, Section 1 to correct a typographical error associated with
the numbering in the Rulebook. The Exchange filed a proposed rule
change which was recently approved,\4\ which caused duplicative
numbering in the Rulebook. The purpose of this filing is administrative
in nature; the Exchange solely desires to correct the numbering in
Chapter VI, Section 1. There are no substantive changes being made in
this proposed rule change.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 34-73784 (December 8,
2014), 79 FR 73930 (December 12, 2014) (SR-BX-2014-049). The filing
attempted to add new subsection (e)(1) to BX Options Chapter VI,
Section 1, a subsection that already contained other text.
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to renumber the second (1) in
Chapter IV, Section 1(e), related to a Directed Order, and continue
numbering the paragraphs thereafter. The Exchange is also proposing to
remove Chapter IV, Sections 1(e)(4) and (7) which are currently
reserved.
 2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by correcting a typographical error in the BX Rulebook. The Exchange
believes that correcting the error will avoid confusion when referring
to the Rulebook. The proposed amendments are non-substantive.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change
corrects a typographical error in the Rulebook and is non-substantive.
This proposed rule change will not impact competition in any respect.

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6)
thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange states that the proposal does not affect the
protection of investors or the public interest, because it is designed
solely to correct a typographical error. Similarly, the Exchange states
that the change does not impact competition in any respect. The
Exchange notes that a waiver of the 30-day operative delay will allow
the correction to the Rulebook to take effect immediately, thereby
avoiding any confusion when referring to the Rulebook. For this reason,
the Commission believes that waiver of the 30-day operative delay is
consistent with the protection of investors and the public interest.
Therefore, the Commission designates the proposed rule change to be
operative upon filing.\9\
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    \9\ For purposes only of waiving the 30-day operative delay, the
Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend 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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2015-008 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2015-008. This file
number should be included on the subject line if email 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
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. 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-BX-2015-008 and should be
submitted on or before March 4, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-02749 Filed 2-10-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96007-96008]
[FR Doc No: 2016-31628]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Identification and Characterization of the Infectious Disease
Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products;
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Identification and Characterization of the
Infectious Disease Risks of Human Cells, Tissues, and Cellular and
Tissue-based Products.'' The purpose of the public workshop is to have
a scientific discussion of the current methods available for
identifying and characterizing infectious disease risks associated with
human cells, tissues, and cellular and tissue-based products (HCT/Ps).

DATES: The public workshop will be held on February 8, 2017, from 8:30
a.m. to 4:30 p.m., and February 9, 2017, from 8:30 a.m. to 12:30 p.m.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at the Wiley Auditorium
located in the Harvey H. Wiley Federal Building, 5100 Campus Dr.,
College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Monica Kapoor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3111C, Silver Spring, MD 20993,
<EMAIL_ADDRESS>or Stacey Rivette, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3109B, Silver Spring, MD 20993,
<EMAIL_ADDRESS>with the subject line titled ``HCT/P
Workshop.''

SUPPLEMENTARY INFORMATION:

I. Background

    Transplantation of HCT/Ps represents an area of medicine important
for saving and/or enhancing the lives of millions of individuals every
year. In order to assure the safety of patients receiving HCT/P
transplants, FDA issued regulations to prevent the introduction,
transmission, or spread of communicable diseases by HCT/Ps under part
1271 (21 CFR part 1271) (May 25, 2004; 69 FR 29786). These regulations
became effective on May 25, 2005. The regulations under part 1271,
subpart C, contain the requirements for

tissue establishments for determining HCT/P donor eligibility. These
requirements include the need to screen and test potential donors of
HCT/Ps for relevant communicable disease agents and diseases (RCDADs).
    The regulations under part 1271, subpart C, list the following
RCDADs for all cells and tissues: Human immunodeficiency virus, types 1
and 2; hepatitis B virus; hepatitis C virus; human transmissible
spongiform encephalopathy; and Treponema pallidum. These regulations
also list human T-lymphotropic virus type I and type II as RCDADs for
viable, leukocyte- rich cells and tissues. For reproductive cells or
tissues, a disease agent or disease of the genitourinary tract includes
Chlamydia trachomatis and Neisseria gonorrhea. In addition, the
regulations under part 1271, subpart C, recognize that over time as new
infectious diseases emerge there would be the need to designate
additional RCDADs. The regulations describe the criteria for
identifying new RCDADs. These criteria include that the disease or
disease agent is potentially transmissible by a HCT/P: Either it has
sufficient incidence and/or prevalence to affect the donor population;
or if it were released in a manner to place potential donors at risk
that it could be fatal or life-threatening, and that there were
appropriate screening and legally marketed screening tests available
for it. However, the regulations under part 1271, subpart C, do not
specify the deliberative and scientific processes necessary to apply
the criteria.
    This workshop will describe currently available scientific methods
to characterize both epidemiologic and biological features of emerging
diseases and disease agents, and discuss their potential use in
evaluating HCT/P infectious diseases risks for the purpose of
identifying new RCDADs for the purposes of the HCT/P regulatory
framework. Assessing the overall risk of a particular disease agent or
disease to recipients of HCT/Ps requires consideration of multiple
factors, including the presence of the disease agent or disease in the
HCT/P donor population, potential for transmission by an HCT/P, and the
potential morbidity or mortality in the recipient. In many cases,
information for one or more of these factors may be limited or
incomplete.

II. Topics for Discussion at the Public Workshop

    The workshop is intended as a scientific discussion regarding the
current methods available to identify and characterize infectious
disease risks related to HCT/Ps. Topics discussed will include: (1)
Estimating disease incidence and/or prevalence in the potential HCT/P
donor population, (2) assessing the potential transmissibility of a
disease by HCT/Ps, and (3) understanding the capabilities of current
screening and testing methodologies. The workshop will also include
discussion on how available information can be used to characterize the
overall infectious disease risks posed by HCT/Ps.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following Web site at https://www.eventbrite.com/e/identification-and-characterization-of-hctp-infectious-disease-risks-public-workshop-registration-24465329459. Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by February 6, 2017. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation once they have been accepted. Attendance for this workshop
is in-person only. FDA will post the agenda approximately 5 days before
the workshop at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.
    If you need special accommodations because of disability, please
contact Monica Kapoor or Stacey Rivette no later than 7 days in advance
of the meeting by email at<EMAIL_ADDRESS>with the
subject line titled ``HCT/P Workshop.''
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A link to the transcript will also be
available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm525001.html.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31628 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63908-63911]
[FR Doc No: 2012-25501]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68037; File No. SR-FINRA-2012-045]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Order Granting Accelerated
Approval of Proposed Rule Change To Amend NASD Rule 2711 and
Incorporated NYSE Rule 472 To Conform With the Requirements of the
Jumpstart Our Business Startups Act and Related Changes

October 11, 2012.

I. Introduction

    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 September 28, 2012, 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 substantially been prepared by
FINRA. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons and to approve the
proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend NASD Rule 2711 (Research Analysts and
Research Reports) to conform with the requirements of the Jumpstart Our
Business Startups Act (``JOBS Act'') \3\ and make certain additional
changes to quiet period restrictions consistent with the policies
underlying the JOBS Act. The proposed rule change also makes conforming
amendments to Incorporated NYSE Rule 472 (Communications With The
Public).
---------------------------------------------------------------------------

    \3\ Pub. L. No. 112-106, 126 Stat. 306.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, and at
the Commission's Public Reference Room.

III. 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
    The JOBS Act was signed into law on April 5, 2012. Among other
things, the JOBS Act is intended to help facilitate capital formation
for ``emerging growth companies'' (``EGCs'') by improving the
information flow about EGCs to investors. To that end, Section 105(b)
of the JOBS Act amended Section 15D of the Act to prohibit the
Commission or any national securities association from adopting or
maintaining any rule or regulation in connection with an initial public
offering (``IPO'') of an EGC that:
     Restricts, based on functional role, which associated
persons of a broker, dealer, or member of a national securities
association, may arrange for communications between an analyst and a
potential investor; or

     restricts a securities analyst from participating in any
communication with the management of an EGC that is also attended by
any other associated person of a broker, dealer, or member of a
national securities association whose functional role is other than as
a securities analyst.

Section 105(d) further prohibits the Commission or any national
securities association from adopting or maintaining any rule or
regulation that prohibits a broker or dealer from publishing or
distributing any research report or making a public appearance, with
respect to the securities of an EGC either:
     within any prescribed period of time following the IPO
date of the EGC; or
     within any prescribed period of time prior to the
expiration date of any agreement between the broker, dealer, or member
of a national securities association and the EGC or its shareholders
that restricts or prohibits the sale of securities held by the EGC or
its shareholders after the IPO date.
    These provisions became effective upon signature of the President
on April 5, 2012. On August 22, 2012, the SEC's Division of Trading and
Markets provided guidance on these provisions in the form of Frequently
Asked Questions (``FAQs'').\4\ FINRA is amending the applicable
provisions of NASD Rule 2711 to conform with the JOBS Act and SEC staff
guidance with regard to the applicable JOBS Act provisions.\5\
---------------------------------------------------------------------------

    \4\ These FAQs are available at http://www.sec.gov/divisions/marketreg/tmjobsact-researchanalystsfaq.htm.
    \5\ FINRA notes that the SEC staff guidance interprets the JOBS
Act provisions as applicable to Incorporated NYSE Rule 472 to the
same extent as NASD Rule 2711. As such, the proposed rule change
makes corresponding amendments to Incorporated NYSE Rule 472.
---------------------------------------------------------------------------

Arranging and Participating in Communications
    NASD Rule 2711(c)(4) \6\ prohibits a research analyst from
participating ``in efforts to solicit investment banking business,''
including any ``pitches'' for investment banking business or other
communications with companies for the purpose of soliciting investment
banking business. The FAQs interpret the JOBS Act to now allow, in
connection with an IPO of an EGC, research analysts to attend meetings
with issuer management that are also attended by investment banking
personnel, including pitch meetings, but not ``engage in otherwise
prohibited conduct in such meetings,'' including ``efforts to solicit
investment banking business.'' The FAQs further explain that a research
analyst that attends a pitch meeting ``could, for example, introduce
themselves, outline their research program and the types of factors
that the analyst would consider in his or her analysis of a company,
and ask follow-up questions to better understand a factual statement
made by the [EGC]'s management.'' Accordingly, the proposed rule change
creates an exception to NASD Rule 2711(c)(4) to reflect this guidance
regarding the application of the JOBS Act.\7\
---------------------------------------------------------------------------

    \6\ See also Incorporated NYSE Rule 472(b)(5).
    \7\ A corresponding exception is created for Incorporated NYSE
Rule 472(b)(5).
---------------------------------------------------------------------------

    The FAQs state that under Section 105(b) of the JOBS Act, an
associated person of a broker-dealer, including investment banking
personnel, may arrange communications between research analysts and
investors in connection with an IPO of an EGC. As an example, the FAQs
state that an investment banker could forward a list of clients to a
research analyst that the analyst could, ``at his or her own discretion
and with appropriate controls, contact.'' The FAQs acknowledge that
FINRA does not have a rule that directly prohibits this activity and
further states that such activity, without more, would not constitute
conduct by investment banking personnel to directly or indirectly
direct a research analyst to engage in sales or marketing efforts
related to an investment banking services transaction, in violation of
NASD Rule 2711(c)(6).\8\ Accordingly, this JOBS Act provision requires
no conforming rule change.
---------------------------------------------------------------------------

    \8\ See also Incorporated NYSE Rule 427(b)(6)(ii). In 2003 and
2004, the Commission, self-regulatory organizations, and other
regulators instituted settled enforcement actions against 12 broker-
dealers to address conflicts of interest between the firms' research
and investment banking functions (``Global Settlement''). As the
FAQs point out, firms subject to the Global Settlement should also
be mindful of the requirements of that court order as they remain in
place.
---------------------------------------------------------------------------

Quiet Periods
    Section 105(d) of the JOBS Act expressly permits publication of
research and public appearances with

respect to the securities of an EGC any time after the IPO of an EGC or
prior to the expiration of any lock up agreement. While the JOBS Act
refers only to the ``expiration'' of a lock-up agreement, the FAQs note
a SEC staff belief that Congress intended for the JOBS Act provisions
to apply equally to the period before a ``waiver'' or ``termination''
of a lock-up agreement. Thus, in accordance with SEC staff guidance on
this JOBS Act provision, the proposed rule change amends NASD Rule 2711
to eliminate the following quiet periods with respect to an IPO of an
EGC:
     NASD Rule 2711(f)(1)(A),\9\ which imposes a 40-day quiet
period after an IPO on a member that acts as a manager or co-manager of
such IPO;
---------------------------------------------------------------------------

    \9\ See also Incorporated NYSE Rule 472(f)(1).
---------------------------------------------------------------------------

     NASD Rule 2711(f)(2),\10\ which imposes a 25-day quiet
period after an IPO on a member that participates as an underwriter or
dealer (other than manager or co-manager) of such an IPO; and
---------------------------------------------------------------------------

    \10\ See also Incorporated NYSE Rule 472(f)(3).
---------------------------------------------------------------------------

     NASD Rule 2711(f)(4) \11\ with respect to the 15-day quiet
period applicable to IPO managers and co-managers prior to the
expiration, waiver, or termination of a lock-up agreement or any other
agreement that such member has entered into with a subject company or
its shareholders that restricts or prohibits the sale of securities
held by the subject company or its shareholders after the completion of
an IPO.
---------------------------------------------------------------------------

    \11\ See also Incorporated NYSE Rule 472(f)(4).
---------------------------------------------------------------------------

    The FAQs note that the JOBS Act makes no reference to quiet periods
after a secondary offering or during a period of time after expiration,
termination, or waiver of a lock-up agreement. Accordingly, the FAQs
note that NASD Rule 2711(f)(1)(B),\12\ which imposes a 10-day quiet
period on managers and co-managers following a secondary offering and
the remaining portion of NASD Rule 2711(f)(4) \13\ relating to quiet
periods after the expiration, termination or waiver of a lock up
agreement, remain fully in effect. Nonetheless, the FAQs express the
SEC staff's belief that the policies underlying the JOBS Act are
equally applicable to quiet periods during these other times. FINRA
agrees that elimination of those quiet periods would advance the policy
objectives of the JOBS Act and therefore has proposed to amend NASD
Rule 2711 accordingly.\14\
---------------------------------------------------------------------------

    \12\ See also Incorporated NYSE Rule 472(f)(2).
    \13\ See also Incorporated NYSE Rule 472(f)(4).
    \14\ A corresponding change is made to Incorporated NYSE Rule
472(f).
---------------------------------------------------------------------------

    FINRA has requested the Commission to find good cause pursuant to
Section 19(b)(2) of the Act \15\ for approving the proposed rule change
prior to the 30th day after its publication in the Federal Register so
that FINRA can implement changes to conform with the JOBS Act, which
has been effective since April 5, 2012. The proposed changes to NASD
Rules 2711(c)(4), (f)(1)(A), (f)(2), and (f)(4) (with respect to the
15-day quiet period before the expiration, termination or waiver of a
lock-up agreement) and the corresponding changes to Incorporated NYSE
Rule 472 would be effective as of April 5, 2012. FINRA requests that
the proposed changes to NASD Rules 2711(f)(1)(B) and (f)(4) (with
respect to the 15-day quiet period after the expiration, termination or
waiver of a lock-up agreement) and the corresponding changes to
Incorporated NYSE Rule 472, which further the policies underlying the
statutory mandates, become effective upon Commission approval.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\16\ 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. FINRA believes that the changes to NASD Rules
2711(c)(4),\17\ (f)(1)(A),\18\ (f)(2),\19\ and (f)(4) \20\ (with
respect to the 15-day quiet period before the expiration, termination
or waiver of a lock-up agreement) and the corresponding changes to
Incorporated NYSE Rule 472 conform those rules to statutory mandates.
FINRA also believes that the proposed additional changes to NASD Rules
2711(f)(1)(B) \21\ and (f)(4) \22\ further the policies underlying the
statutory mandates by improving information flow to investors with
respect to EGCs without sacrificing the reliability of research
reports, as the other objectivity safeguards in NASD Rule 2711 \23\ and
SEC Regulation AC \24\ are effective and will continue to apply.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78o-3(b)(6).
    \17\ See also Incorporated NYSE Rule 472(b)(5).
    \18\ See also Incorporated NYSE Rule 472(f)(1).
    \19\ See also Incorporated NYSE Rule 472(f)(3).
    \20\ See also Incorporated NYSE Rule 472(f)(4).
    \21\ See also Incorporated NYSE Rule 472(f)(2).
    \22\ See also Incorporated NYSE Rule 472(f)(4).
    \23\ See also Incorporated NYSE Rule 472.
    \24\ 17 CFR 242.500-05.
---------------------------------------------------------------------------

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, as amended by the JOBS 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.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2012-045 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-2012-045. This
file number should be included on the subject line if email 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 such 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-2012-045 and should be submitted
on or before November 7, 2012.

V. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    After careful review of the proposed rule change, the Commission
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities association.\25\ In particular, the Commission
finds that the proposed rule change is consistent with Section
15A(b)(6) of the Act.\26\ The proposal primarily reflects the changes
imposed on FINRA's rules by Sections 105(b) and 105(d) of the JOBS Act
and thus is primarily updating the language of NASD Rule 2711 and
Incorporated NYSE Rule 472 to reflect that reality. The one change not
expressly mandated by the JOBS Act, removing the quiet periods
regarding the secondary offering of the securities of EGCs and after
the expiration, termination, or waiver of a lock-up regarding such
securities, is consistent with the purpose of the JOBS Act as part of
an effort to improve communications with investors regarding EGCs.
Furthermore, other safeguards designed to protect the objectivity of
research and provide investors with more useful and reliable
information remain in effect, including Regulation AC and the parts of
NASD Rule 2711 and Incorporated NYSE Rule 472 not affected by these
changes.
---------------------------------------------------------------------------

    \25\ In approving this rule change, the Commission notes that it
has considered the proposed rule change's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \26\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    In its filing, FINRA has requested that the Commission find good
cause for approving the proposed rule change prior to the 30th day
after publication in the Federal Register. FINRA cites as the reason
for this request is because the changes conforming to the JOBS Act have
been effective since April 5, 2012 and the additional proposed changes
further the policies underlying the applicable JOBS Act provision.
    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\27\ for approving the proposed rule change prior to the 30th
day after the date of publication of notice in the Federal Register
because the changes required by the JOBS Act have been in effect since
April 5, 2012 and the additional proposed changes further the policies
underlying the applicable JOBS Act provision.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-FINRA-2012-045) be, and hereby is,
approved on an accelerated basis.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25501 Filed 10-16-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]
[Page 13547-13548]
[DOCID:fr22mr10-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0117]

Agency Information Collection Activities; Proposed Collection:
Comment Request: Guidance for Industry Entitled Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims

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,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
the guidance ``Hypertension Indication: Drug Labeling for
Cardiovascular Outcome Claims,'' which is intended to assist applicants
in developing labeling for outcome claims for drugs that are indicated
to treat hypertension.

DATES:  Submit written or electronic comments on the collection of
information by May 21, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://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
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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 that 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.

Guidance for Industry entitled ``Hypertension Indication: Drug Labeling
for Cardiovascular Outcome Claims'' 21 CFR 201.56 and 201.57--(OMB
Control Number 0910--New)

    This guidance is intended to assist applicants in developing
labeling for outcome claims for drugs that are indicated to treat
hypertension. With few exceptions, current labeling for
antihypertensive drugs includes only the information that these drugs
are indicated to reduce blood pressure; the labeling does not include
information on the clinical benefits related to cardiovascular outcomes
expected from such blood pressure reduction. However, blood pressure
control is well established as beneficial in preventing serious
cardiovascular events, and inadequate treatment of hypertension is
acknowledged as a significant public health problem. FDA believes that
the appropriate use of these drugs can be encouraged by making the
connection between lower blood pressure and improved cardiovascular
outcomes more explicit in labeling. The intent of the guidance is to
provide common labeling for antihypertensive drugs except where
differences are clearly supported by clinical data. The guidance
encourages applicants to submit labeling supplements containing the new
language.
    In the Federal Register of March 13, 2008 (73 FR 13546), FDA
published the draft guidance entitled ``Hypertension Indication: Drug
Labeling for Cardiovascular Outcome Claims.'' The draft guidance
contained no information collection subject to OMB review under the
PRA. The final guidance, however, contains two new provisions that are
subject to OMB review and approval under the PRA, and one new provision
that would be exempt from OMB review. Under the PRA, FDA must first
obtain OMB approval for this information collection before we may issue
the final guidance.
    (1) Section IV.C of the guidance requests that the CLINICAL STUDIES
section of the Full Prescribing Information of the labeling should
include a summary of placebo- or active-controlled trials showing
evidence of the specific drug's effectiveness in lowering blood
pressure. If trials demonstrating cardiovascular outcome benefits
exist, those trials also should be summarized in this section. Table 1
in section V of the guidance contains the specific drugs for which the
FDA has concluded that such trials exist. If there are no
cardiovascular outcome data to cite, one of the following two
paragraphs should appear:
    ``There are no trials of [DRUGNAME] or members of the [name of
pharmacologic class] pharmacologic class demonstrating reductions in
cardiovascular risk in patients with hypertension,'' or ``There are no
trials of [DRUGNAME] demonstrating reductions in cardiovascular risk in
patients with hypertension, but at least one pharmacologically similar
drug has demonstrated such benefits.''
In the latter case, the applicant's submission generally should refer
to table 1 in section V of the guidance. If the applicant believes that
table 1 is incomplete, it should submit the clinical evidence for the
additional information to Docket No. FDA-2008-D-0150. The labeling
submission should reference the submission to the docket. FDA estimates
that no more than 1 submission to the docket will be made annually from
1 company, and that each submission will take approximately 10 hours to
prepare and submit. Concerning the

recommendations for the CLINICAL STUDIES section of the Full
Prescribing Information of the labeling, FDA regulations at Sec. Sec.
201.56 and 201.57 (21 CFR 201.56 and 201.57) require such labeling, and
the information collection associated with these regulations is
approved by OMB under OMB Control Number 0910-0572.
    (2) Section VI.B of the guidance requests that the format of
cardiovascular outcome claim prior approval supplements submitted to
FDA under the guidance should include the following information:
    1. A statement that the submission is a cardiovascular outcome
claim supplement, with reference to the guidance and related Docket No.
FDA-2008-D-0150
    2. Applicable FDA forms (e.g., 356h, 3397)
    3. Detailed Table of Contents
    4. Revised labeling:
    a. Include draft revised labeling conforming to the requirements in
Sec. Sec.  201.56 and 201.57
    b. Include marked-up copy of the latest approved labeling, showing
all additions and deletions, with annotations of where supporting data
(if applicable) are located in the submission
    FDA estimates that approximately 70 cardiovascular outcome claim
supplements will be submitted annually from approximately 30 different
companies, and that each supplement will take approximately 4 hours to
prepare and submit. The guidance also recommends that other labeling
changes (e.g., the addition of adverse event data) should be minimized
and provided in separate supplements, and that the revision of labeling
to conform to Sec. Sec.  201.56 and 201.57 may require substantial
revision to the ADVERSE REACTIONS or other labeling sections.
    (3) Section VI.C of the guidance states that applicants are
encouraged to include the following statement in promotional materials
for the drug.
    ``[DRUGNAME] reduces blood pressure, which reduces the risk of
fatal and nonfatal cardiovascular events, primarily strokes and
myocardial infarctions. Control of high blood pressure should be part
of comprehensive cardiovascular risk management, including, as
appropriate, lipid control, diabetes management, antithrombotic
therapy, smoking cessation, exercise, and limited sodium intake. Many
patients will require more than one drug to achieve blood pressure
goals.''
The inclusion of this statement in the promotional materials for the
drug would be exempt from OMB review based on 5 CFR 1320.3(c)(2), which
states that ``The public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public is not included * * * '' within the definition
of ``collection of information.''
    FDA requests public comments on the information collection
provisions described previously and set forth in the following table:
    FDA estimates the burden of this collection of information as
follows:

                                                            Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of       Number of Responses     Total Annual        Hours Per
                                                           Respondents        per Respondent         Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission to Docket Number FDA-2008-D-0150                             1                     1                  1                 10                 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiovascular Outcome Claim Supplement Submission                     30                  2.33                 70                  4                280
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                290
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: March 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6173 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S