[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Rules and Regulations]
[Pages 5577-5579]
[FR Doc No: 2016-01857]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31055; Amdt. No. 3677]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective February 3, 2016. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 3, 2016.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420), Flight Technologies and Programs
Divisions, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125),
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPs, Takeoff Minimums and/or ODPs.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find

that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C 553(d), good cause exists for making some
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR part 97:

    Air traffic control, airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC on December 31, 2015.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

Part 97--Standard Instrument Approach Procedures

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 4 FEBRUARY 2016

Gulkana, AK, Gulkana, VOR/DME RWY 33, Orig, CANCELED
Kotzebue, AK, Ralph Wien Memorial, VOR/DME RWY 9, Orig-B
Kotzebue, AK, Ralph Wien Memorial, VOR/DME Y RWY 27, Orig, CANCELED
Yakutat, AK, Yakutat, VOR/DME RWY 11, Amdt 3A, CANCELED
Harrison, AR, Boone County, VOR-A, Amdt 13, CANCELED
Rogers, AR, Rogers Executive--Carter Field, NDB RWY 20, Amdt 1A,
CANCELED
Sheridan, AR, Sheridan Muni, RNAV (GPS) RWY 1, Orig
Los Angeles, CA, Los Angeles Intl, ILS OR LOC RWY 6, Amdt 17C,
SUSPENDED
Los Angeles, CA, Los Angeles Intl, RNAV (GPS) Y RWY 6R, Amdt 1B,
SUSPENDED
Los Angeles, CA, Los Angeles Intl, RNAV (RNP) Z RWY 6R, Orig-B,
SUSPENDED
Sacramento, CA, McClellan Airfield, VOR/DME RWY 16, Orig-C, CANCELED
San Jose, CA, Norman Y Mineta San Jose Intl, VOR RWY 12R, Amdt 5,
CANCELED
San Jose, CA, Norman Y Mineta San Jose Intl, VOR/DME RWY 30L, Amdt
3, CANCELED
San Jose, CA, Norman Y Mineta San Jose Intl, VOR/DME RWY 30R, Amdt
1, CANCELED
New Haven, CT, Tweed-New Haven, VOR-A, Amdt 3, CANCELED
Umatilla, FL, Umatilla Muni, RNAV (GPS) RWY 19, Orig-B
Pohnpei Island, FM, Pohnpei Intl, RNAV (RNP) Y RWY 9, Orig
Pohnpei Island, FM, Pohnpei Intl, RNAV (RNP) Z RWY 9, Orig
Jefferson, GA, Jackson County, RNAV (GPS) RWY 17, Amdt 3
Jefferson, GA, Jackson County, RNAV (GPS) RWY 35, Amdt 3
Jefferson, GA, Jackson County, Takeoff Minimums and Obstacle DP,
Amdt 3
Macon, GA, Macon Downtown, VOR/DME-B, Amdt 3, CANCELED
Nashville, GA, Berrien CO, GPS RWY 10, Orig-B, CANCELED
Nashville, GA, Berrien CO, RNAV (GPS) RWY 10, Orig
Nashville, GA, Berrien CO, RNAV (GPS) RWY 28, Orig
Tifton, GA, Henry Tift Myers, VOR RWY 33, Amdt 11C, CANCELED
Waycross, GA Waycross-Ware County, ILS Y OR LOC Y RWY 19, Orig
Waycross, GA Waycross-Ware County, ILS Z OR LOC Z RWY 19, Amdt 3
Waycross, GA Waycross-Ware County, RNAV (GPS) RWY 1, Amdt 2
Waycross, GA Waycross-Ware County, RNAV (GPS) RWY 19, Amdt 2
Waycross, GA Waycross-Ware County, Takeoff Minimums and Obstacle DP,
Amdt 2
Sibley, IA, Sibley Muni, NDB OR GPS RWY 17, Amdt 1C, CANCELED
Waterloo, IA, Waterloo Rgnl, VOR/DME RWY 30, Amdt 15, CANCELED
Twin Falls, ID, Joslin Field--Magic Valley Rgnl, NDB RWY 26, Amdt 7,
CANCELED
Olney-Noble, IL, Olney-Noble, NDB RWY 3, Amdt 14
Olney-Noble, IL, Olney-Noble, RNAV (GPS) RWY 3, Orig-B
Olney-Noble, IL, Olney-Noble, RNAV (GPS) RWY 11, Amdt 1B
Rochelle, IL, Rochelle Muni Airport-Koritz Field, Takeoff Minimums
and Obstacle DP, Amdt 4
Indianapolis, IN, Eagle Creek Airpark, NDB RWY 21, Amdt 4, CANCELED
Nappanee, IN, Nappanee Muni, VOR/DME OR GPS-A, Amdt 3B, CANCELED
Terra Haute, IN, Sky King, VOR-B, Orig-B, CANCELED
Goodland, KS, Renner Fld/Goodland Muni/, VOR/DME RWY 30, Amdt 8B,
CANCELED
Richmond, KY, Madison, RNAV (GPS) RWY 18, Amdt 1C
Richmond, KY, Madison, RNAV (GPS) RWY 36, Amdt 2A
Abbeville, LA, Abbeville Chris Crusta Memorial, VOR/DME-A, Amdt 2B,
CANCELED
New Roads, LA, False River Rgnl, VOR/DME-A, Amdt 4A, CANCELED
Fitchburg, MA, Fitchburg Muni, RNAV (GPS) RWY 20, Orig-C
Lawrence, MA, Lawrence Muni, NDB RWY 5, Amdt 6, CANCELED
Bangor, ME, Bangor Intl, VOR/DME RWY 15, Amdt 4A, CANCELED
Bangor, ME, Bangor Intl, VOR/DME RWY 33, Amdt 7, CANCELED
Hancock, MI, Houghton County Memorial, VOR RWY 31, Amdt 14A,
CANCELED
Ironwood, MI, Gogebic-Iron County, VOR/DME RWY 27, Amdt 9, CANCELED
Marquette, MI, Sawyer Intl, NDB RWY 1, Orig-B, CANCELED
Marquette, MI, Sawyer Intl, VOR RWY 1, Orig, CANCELED
Pellston, MI, Pellston Rgnl Airport of Emmet County, VOR/DME RWY 5,
Amdt 12A, CANCELED
Sault Ste Marie, MI, Chippewa County Intl, VOR-A, Amdt 7, CANCELED
Marshall, MN, Southwest Minnesota Rgnl Marshall/Ryan Fld, VOR/DME
RWY 30, Amdt 2B, CANCELED
Minneapolis, MN, Anoka County-Blaine Arpt (Janes Field), VOR/DME RWY
27, Amdt 5, CANCELED
Owatonna, MN, Owatonna Degner Rgnl, VOR/DME RWY 30, Amdt 4, CANCELED
Thief River Falls, MN, Thief River Falls Rgnl, VOR/DME RWY 31, Amdt
3C, CANCELED
Kirksville, MO, Kirksville Rgnl, VOR/DME-B, Amdt 7, CANCELED
Sikeston, MO, Sikeston Memorial Muni, VOR/DME RWY 2, Amdt 3A,
CANCELED
Greensboro, NC, Piedmont Triad Intl, VOR RWY 5R, Amdt 13B, CANCELED
Beatrice, NE., Beatrice Muni, VOR RWY 14, Amdt 18B, CANCELED
Manchester, NH, Manchester, VOR/DME RWY 17, Orig-E, CANCELED
Trenton, NJ, Trenton Mercer, RNAV (GPS) RWY 16, Orig-B
Trenton, NJ, Trenton Mercer, RNAV (GPS) RWY 34, Orig-B
Silver City, NM, Grant County, VOR/DME-B, Amdt 3B, CANCELED
Ely, NV, Ely Arpt/Yelland Fld/, VOR-A, Amdt 7A, CANCELED
Binghamton, NY, Greater Binghamton/Edwin A Link Field, VOR/DME RWY
28, Amdt 11A, CANCELED
Plattsburgh, NY, Plattsburgh Intl, ILS OR LOC RWY 35, Amdt 1
Plattsburgh, NY, Plattsburgh Intl, RNAV (GPS) RWY 35, Amdt 2
Plattsburgh, NY, Plattsburgh Intl, VOR/DME RWY 35, Orig-B, CANCELED
Poughkeepsie, NY, Dutchess County, VOR/DME RWY 6, Amdt 7B, CANCELED
Batavia, OH, Clermont County, NDB RWY 22, Amdt 1C, CANCELED
Dayton, OH, James M Cox Dayton Intl, NDB RWY 6R, Amdt 9, CANCELED
Bartlesville, OK, Bartlesville Muni, LOC RWY 17, Amdt 3B
Bartlesville, OK, Bartlesville Muni, RNAV (GPS) RWY 17, Amdt 1

Bartlesville, OK, Bartlesville Muni, RNAV (GPS) RWY 35, Amdt 1
Chickasha, OK, Chickasha Muni, RNAV (GPS) RWY 18, Amdt 1A
Chickasha, OK, Chickasha Muni, RNAV (GPS) RWY 36, Amdt 1A
Claremore, OK, Claremore Regional, VOR/DME-A, Amdt 2A, CANCELED
Durant, OK, Durant Rgnl--Eaker Field, VOR/DME RWY 17, Orig, CANCELED
Eagle Butte, SD, Cheyenne Eagle Butte, Takeoff Minimums and Obstacle
DP, Orig-A
Watertown, SD, Watertown Rgnl, VOR/DME OR TACAN RWY 35, Amdt 11B,
CANCELED
Castroville, TX, Castroville Muni, RNAV (GPS) RWY 16, Amdt 1A
Corsicana, TX, C David Campbell Field-Corsicana Muni, VOR/DME-B,
Amdt 1B, CANCELED
Dallas-Fort Worth, TX, Dallas/Fort Worth Intl, VOR RWY 31L, Orig-C,
CANCELED
Del Rio, TX, Del Rio Intl, NDB RWY 13, Amdt 1, CANCELED
Granbury, TX, Granbury Rgnl, VOR/DME-A, Orig-C, CANCELED
Houston, TX, William P Hobby, VOR/DME RWY 4, Amdt 18A, CANCELED
Houston, TX, William P Hobby, VOR/DME RWY 30L, Amdt 18A, CANCELED
Houston, TX, William P Hobby, VOR/DME-E, Orig, CANCELED
Longview, TX, East Texas Rgnl, NDB RWY 13, Amdt 15, CANCELED
Sulphur Springs, TX, Sulphur Springs Muni, VOR-A, Amdt 4, CANCELED
Wichita Falls, TX, Wichita Valley, VOR/DME-C, Amdt 2, CANCELED
Salt Lake City, UT, Salt Lake City Intl, VOR/DME RWY 34R, Amdt 9A,
CANCELED
Salt Lake City, UT, Salt Lake City Intl, VOR/DME OR TACAN RWY 16L,
Amdt 2, CANCELED
Salt Lake City, UT, Salt Lake City Intl, VOR/DME OR TACAN RWY 17,
Amdt 2A, CANCELED
Newport News, VA, Newport News/Williamsburg Intl, NDB RWY 20, Amdt
5A, CANCELED
Norfolk, VA, Norfolk Intl, VOR RWY 23, Amdt 8D, CANCELED
Norfolk, VA, Norfolk Intl, VOR/DME RWY 5, Amdt 4D, CANCELED
Rutland, VT, Rutland--Southern Vermont Rgnl, VOR/DME RWY 19, Amdt 1,
CANCELED
Bremerton, WA, Bremerton National, RNAV (GPS) RWY 2, Amdt 2
Burlington/Mount Vernon, WA, Skagit Rgnl, NDB RWY 11, Amdt 5A
Burlington/Mount Vernon, WA, Skagit Rgnl, RNAV (GPS) RWY 11, Amdt 2A
Burlington/Mount Vernon, WA, Skagit Rgnl, RNAV (GPS) RWY 29, Amdt 2
Burlington/Mount Vernon, WA, Skagit Rgnl, Takeoff Minimums and
Obstacle DP, Amdt 2A
Hoquiam, WA, Bowerman, VOR/DME RWY 24, Amdt 6B, CANCELED
Walla Walla, WA, Walla Walla Rgnl, NDB RWY 20, Amdt 6A, CANCELED
Green Bay, WI, Austin Straubel Intl, VOR/DME OR TACAN RWY 36, Amdt
10, CANCELED
La Crosse, WI, La Crosse Rgnl, NDB RWY 18, Amdt 19B, CANCELED
Madison, WI, Dane County Rgnl-Truax Field, ILS OR LOC RWY 21, Orig-C
Madison, WI, Dane County Rgnl-Truax Field, ILS OR LOC/DME RWY 18,
ILS RWY 18 (SA CAT I), ILS RWY 18 (SA CAT II), Amdt 2
Madison, WI, Dane County Rgnl-Truax Field, ILS OR LOC/DME RWY 36,
ILS RWY 36 (SA CAT I), ILS RWY 36 (CAT II), ILS RWY 36 (CAT III),
Amdt 2
Madison, WI, Dane County Rgnl-Truax Field, RADAR-1, Amdt 18
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 3, Orig-C
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 14, Amdt
2E
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 18, Amdt
2E
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 21, Amdt
2C
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 32, Amdt
2E
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 36, Amdt
2D
Madison, WI, Dane County Rgnl-Truax Field, Takeoff Minimums and
Obstacle DP, Amdt 8A
Mosinee, WI, Central Wisconsin, VOR OR GPS-A, Amdt 8A, CANCELED

[FR Doc. 2016-01857 Filed 2-2-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21244-21246]
[FR Doc No: 2020-08011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0804]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by May 18, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0120. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Notification Procedures--21 CFR Part 807, Subpart E

OMB Control Number 0910-0120--Revision

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360(k)) and implementing regulations in part 807 (21
CFR part 807, subpart E) require a premarket notification submission
(``510(k)'') at least 90 days before the introduction, or delivery for
introduction into interstate commerce, for commercial distribution of a
device intended for human use. Based on the information provided in the
notification, FDA determines whether the new device is substantially
equivalent to a legally marketed device, as defined in Sec.
807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), product development protocol,
humanitarian device exemption (HDE), request for an evaluation of
automatic class III designation (De Novo request), or be reclassified
into class I or class II before being marketed (see OMB control numbers
0910-0231, 0910-0332, 0910-0844, and 0910-0138). FDA makes the final
decision of whether a device is substantially equivalent or not
substantially equivalent.
    Section 807.81 governs when a 510(k) is required. A 510(k) is
required to be submitted by a person who is: (1) Introducing a device
to the market for the first time; (2) introducing a device into
commercial distribution for the first time by a person who is required
to register; or (3) introducing or reintroducing a device that is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device. Section 807.87 lists the information
required in each 510(k).
    Form FDA 3514, a summary cover sheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, De Novo requests, HDEs, etc.
    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act
(21 U.S.C. 360d). Amended section 514 of the FD&C Act allows FDA to
recognize consensus standards developed by international and national
organizations for use in satisfying portions of device premarket review
submissions including 510(k) or other requirements. FDA has published
and updated regularly the list of recognized standards since enactment
of FDAMA and has allowed 510(k) submitters to certify conformance to
recognized standards to meet the requirements of Sec.  807.87.
    Under Sec.  807.90(a)(3), inquiries regarding a 510(k) submission
should be in writing and sent to one of the addresses in Sec.
807.90(a).
    Under Sec.  807.87(h), each 510(k) submitter must include in the
510(k) either a summary of the information in the 510(k) as required by
Sec.  807.92 (510(k) summary) or a statement certifying that the
submitter will make available upon request the information in the
510(k) with certain exceptions as per Sec.  807.93 (510(k) statement).
    Section 745A(b) of the FD&C Act (21 U.S.C. 379k-1(b), amended by
section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L.
115-52), requires that submissions for devices under section 510(k),
among other submission types, be submitted in electronic format
specified by FDA. In addition, in the Medical Device User

Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary
of Health and Human Services to Congress,\1\ FDA committed to
developing ``electronic submission templates that will serve as guided
submission preparation tools for industry to improve submission
consistency and enhance efficiency in the review process.'' The
Electronic Submission Template and Resource (eSTAR) is such an
electronic submission template for 510(k) submissions to facilitate the
preparation of submissions in electronic format.
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    \1\ See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017)
(Food and Drug Administration User Fee Reauthorization), also
available at https://www.fda.gov/media/102699/download.
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    In the Federal Register of December 30, 2019 (84 FR 71958) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    Upon further evaluation, however, in addition to the revisions
discussed in our 60-day notice, we are also revising the information
collection to include the draft guidance document entitled
``Recognition and Withdrawal of Voluntary Consensus Standards; Guidance
for Industry and Food and Drug Administration Staff.'' The guidance is
being issued consistent with our Good Guidance Practice Regulations in
21 CFR 10.115, which provides for comment at any time.
    Incorporating burden that may be associated with recommendations
discussed in the draft guidance optimizes our operational efficiency
with regard to requests to recognize voluntary consensus standards. The
draft guidance document is available at https://www.fda.gov/media/115964/download and discusses procedures the Center for Devices and
Radiological Health (CDRH) will follow when a request for recognition
of a voluntary consensus standard is received. The draft guidance
outlines justifications for why a standard may be recognized wholly,
partly, or not at all, as well as reasons and rationales for
withdrawing a standard. The draft guidance also discusses that any
interested party may request recognition of a standard and provides
respondents with suggested information to include in a request for
recognition of a standard.
    In the Federal Register of September 14, 2018 (83 FR 46740), we
published a notice announcing the availability of the draft guidance,
including a 60-day notice under the PRA, and invited comment on
proposed collection of information. One comment was received stating,
information ``required'' for a recommendation for recognition of a
standard, a description of how the requirements in the final guidance
have been satisfied should also be included along with information
about the standard and that a copy of the standard needs to be
available to the public at no charge. First, we note that the commenter
is incorrect; the draft guidance document states that the information
in section IV.B. should be provided when requesting recognition, but it
is not required. We believe that requiring a request to include (in
addition to the list of recommended items) information regarding how
each attribute or element of the voluntary consensus standards
development process was met would be unduly burdensome. We remain
active in and aware of many national and international voluntary
consensus standards bodies and, therefore, are knowledgeable of how
these groups address the attributes outlined in OMB Circular A-119,
``Federal Participation in the Development and Use of Voluntary
Consensus Standards and in Conformity Assessment Activities.'' If we
have questions regarding how a specific standard was developed with
respect to the voluntary consensus standards development process, we
may followup with respondents for additional information on a case-by-
case basis (we believe these nonstandardized followup questions
designed to clarify responses would be exempt from OMB review and
approval under 5 CFR 1320.3(h)(9)).
    As indicated in FDA's guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submission for Medical
Devices'': ``The use of consensus standards is not mandatory for
medical device premarket submissions unless the consensus standard has
been incorporated by reference into a regulation. A manufacturer may
choose to rely on applicable consensus standards or address issues
relevant to approval or clearance in another manner.'' Note that the
recognition process is separate from creation of regulations that
incorporate standards by reference. Consistent with OMB Circular A-119,
FDA considers ``reasonable availability'' of a standard when
determining whether to incorporate a standard by reference into
regulation.
    We intend to finalize the guidance and we are seeking OMB approval
of the information collection provisions discussed. We estimate the
burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
 Activity and 21 CFR part; section       Form number         Number of     responses per   Total annual     Average burden per response     Total hours
                                                            respondents     respondent       responses                  \2\                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart E).  FDA 3881............           3,800               1           3,800  79.25.........................         301,150
Summary cover sheet (807.87)......  FDA 3514............           1,906               1           1,906  0.5...........................             953
Status request (807.90(a)(3)).....  ....................               1               1               1  0.25..........................               1
510(k) summary (807.92)...........  ....................           2,725               1           2,725  4.............................          10,900
510(k) statement (807.93).........  ....................             215               1             215  10............................           2,150
510(k) submission (807 subpart E)-- FDA 4062............             100               1             100  40............................           4,000
 via eSTAR.
eSTAR setup--(one-time burden)....  ....................              80               1              80  0.08 (5 minutes)..............               6
Request for recognition of          ....................               9               1               9  1.............................               9
 voluntary consensus standard.
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  ....................  ..............  ..............  ..............  ..............................         319,169
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Upon review of this information collection, we have made the
following changes:
     We have updated the burden estimate consistent with new
provisions in Sec.  807.87(j) regarding ``Human Subject Protection;
Acceptance of Data from Clinical Investigations for Medical Devices''
(83 FR 7366; February 21, 2018) (approved under OMB control number
0910-0741). Section 807.87 was amended to address requirements for
510(k) submissions supported by clinical data. For clinical
investigations conducted in the United States, submitters are required
to submit a statement as described in Sec.  807.87(j)(1). For clinical
investigations conducted outside the United States, submitters are
required to submit the information as described in Sec.  807.87(j)(2).
Consistent with our estimate in OMB control number 0910-0741, this
revision increases our burden estimate for a 510(k) submission by 15
minutes per submission.
     We corrected the burden table to include a line for the
``510(k) Summary'' under Sec.  807.92. This section was inadvertently
removed from the previous version of the information collection request
(ICR).
     We are making available Form FDA 3881 ``Indications for
Use'' that respondents include as part of a medical device 510(k). The
information provided via the form is already approved under this ICR.
The form does not ask for new information and does not bear on the
underlying program or on the hour or cost burden associated with the
information collection, rather it provides a fillable, Section 508-
compliant format for respondents to use for the ``Indications for Use''
portion of their 510(k) submission.
     We updated the guidance ``Refuse to Accept Policy for
510(k)s'' to explicitly recommend providing an Acceptance Checklist in
the 510(k) submission. The guidance previously provided the checklist
as an example of a tool that FDA staff use when reviewing a 510(k)
submission. While it was not explicitly recommended, respondents had
used the example and had included it with their 510(k) submission. We
believe the checklist can be a helpful tool for both reviewers and
510(k) submitters and have therefore updated the guidance to explicitly
recommend inclusion of the checklist in the 510(k) submission. Because
most submitters included the checklist on their own initiative and
because it may simplify preparation of the 510(k), we do not believe
adding the checklist to this ICR affects the overall burden for a
510(k) submission. Additionally, we have updated the checklist to
include combination products, as appropriate. The estimated number of
responses as updated with current data in this submission, reflects the
inclusion of combination products.
     We revised and reformatted Form FDA 3514, ``CDRH Premarket
Review Submission Cover Sheet,'' to improve usability and to be
inclusive of most medical device product submission types. Form FDA
3514, a summary cover sheet form, assists respondents in categorizing
510(k) information for submission to FDA. This form also assists
respondents in categorizing information for other FDA medical device
programs. The total burden for Form FDA 3514 and for the 510(k) program
is estimated in this ICR. The burden for the other medical device
programs listed on Form FDA 3514 are approved under the corresponding
product submission ICRs as follows: Premarket approval applications
(OMB control number 0910-0231), investigational device exemptions (OMB
control number 0910-0078), humanitarian device exemptions (control
number 0910-0332), CLIA waivers (OMB control number 0910-0598), Q-
Submissions (OMB control number 0910-0756), De Novo requests (OMB
control number 0910-0844), Emergency Use Authorizations (OMB control
number 0910-0595), 513(g) requests (OMB control number 0910-0705); and
Appeals (OMB control number 0910-0738).
     Certain revisions to Form FDA 3514, as previously
described, eliminate the need for Form FDA 3654, ``Standards Data
Report for 510(k)s.'' Additionally, the ability for Form FDA 3514 to be
expandable for the number of standards cited will increase awareness of
actual standards in a submission and how they were used on a single
form (compared to including several Form FDA 3654 documents). In the
rare occasions where the sponsor elects to not use Form FDA 3514 for
standards, this would not have any effect on the review outcome, with
regard to standards, as the form serves as a means to identify what
standards are cited, how they are used, and where in the submission
they are located.
     We have removed Form FDA 3541, ``Status Request.'' In
practice, Form FDA 3541 is rarely used. We have adjusted the burden
estimate to reflect this removal. Under Sec.  807.90(a)(3), all
inquiries regarding a premarket notification submission should be in
writing and sent to one of the addresses listed in Sec.  807.90(a).
     We have added burden estimates for the eSTAR and eSTAR
setup (one-time burden). Under section 745A(b) of FD&C Act, amended by
section 207 of FDARA, and consistent with the MDUFA IV Commitment
Letter,\2\ FDA has developed the eSTAR (eSTAR, Form FDA 4062) for
510(k) submissions to facilitate the preparation of submissions in
electronic format. We expect to receive approximately 100 510(k)
submissions via eSTAR per year. We estimate that eSTAR submissions will
take approximately 40 hours per submission. Additionally, we've
estimated a one-time setup burden of 5 minutes for approximately 80 new
eSTAR users annually.
---------------------------------------------------------------------------

    \2\ https://www.fda.gov/media/102699/download.
---------------------------------------------------------------------------

     We have also added Agency guidance to assist respondents
who request recognition of a voluntary consensus standard. The guidance
recommends that respondents provide basic contact information to FDA
along with details about the specific standard recognition request.
Based on previous requests for recognition of standards, we estimate we
will receive nine requests annually and assume that each request will
take less than 1 hour to prepare.
    The adjustments and revisions result in a 39,464-hour decrease in
the total hour burden estimate since the last OMB approval.

    Dated: April 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08011 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Notices]
[Pages 77129-77132]
[FR Doc No: 2012-31238]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68513; File No. SR-Phlx-2012-142]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change With Respect to the Amendment of the By-
Laws of its Parent Corporation, The NASDAQ OMX Group, Inc.

December 21, 2012.
    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 December 19, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III 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.
---------------------------------------------------------------------------

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

    The Exchange proposes a rule change with respect to the amendment
of the by-laws of its parent corporation, The NASDAQ OMX Group, Inc.
(``NASDAQ OMX'' or the ``Corporation''). The text of the proposed rule
change is available at http://nasdaqomxphlx.cchwallstreet.com/nasdaqomxphlx/phlx, at Phlx's principal office, 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
    NASDAQ OMX is proposing amendments to provisions of its By-Laws
pertaining to the compositional requirements of the NASDAQ OMX Board.
The changes are primarily focused on amending the definition of
``Industry Director'' (and ``Industry committee member'') \3\ to make
the definition less restrictive, but in a manner that Phlx believes
will continue to serve the purpose of ensuring that members and member
organizations of Self-Regulatory Subsidiaries \4\--the self-regulatory
organizations owned by NASDAQ OMX--do not have disproportionate
influence on its governance. In making the change, NASDAQ OMX is
adapting concepts already approved by the Commission in its review of
the Independence Policy of the NYSE Euronext Board of Directors (the
``Independence Policy'').\5\ The proposed rule change also makes
several other changes to provisions pertaining to the Board's
compositional requirements and categorization of Directors.
---------------------------------------------------------------------------

    \3\ The term ``committee member'' in the By-Laws refers to
membership in the committees authorized under Section 4.13 of the
By-Laws, such as the Executive Committee and the Audit Committee.
Under the By-Laws and the Delaware General Corporation Law, all
members of committees with the power and authority to act on behalf
of the Board in the management of the business and affairs of NASDAQ
OMX must themselves be Directors. Accordingly, the definitions of
``Industry Director'' and ``Industry committee member'' are
coterminous as applied to any member of these committees. The By-
Laws do not presently contemplate any committees with non-Director
members.
    \4\ The By-Laws define each of The NASDAQ Stock Market LLC
(``NASDAQ''), NASDAQ OMX BX, Inc. (``BX''), Phlx, the Boston Stock
Exchange Clearing Corporation (``BSECC''), and the Stock Clearing
Corporation of Philadelphia (``SCCP'') as a ``Self-Regulatory
Subsidiary''.
    \5\ Securities Exchange Act Release No. 51217 (February 16,
2005), 70 FR 9688 (February 28, 2005) (SR-NYSE-2004-54); Securities
Exchange Act Release No. 55293 (February 14, 2007), 72 FR 8033
(February 22, 2007) (SR-NYSE-2006-120); Securities Exchange Act
Release No. 67564 (August 1, 2012), 77 FR 47161) (SR-NYSE-2012-17;
SR-NYSEArca-2012-59; SR-NYSEMKT-2012-07).
---------------------------------------------------------------------------

Definitions
    The By-Laws require Directors to be assigned to certain defined
categories, based on their current and past affiliations.\6\
Specifically, Directors may be categorized as ``Industry Directors,''
``Non-Industry Directors,'' ``Public Directors,'' and/or ``Staff
Directors.'' Currently, an Industry Director is defined as a Director
who:
---------------------------------------------------------------------------

    \6\ As discussed above, the categories also govern the
classification of members of committees of NASDAQ OMX, as provided
for in the By-Laws.
---------------------------------------------------------------------------

    (1) Is or has served in the prior three years as an officer,
director, or employee of a broker or dealer, excluding an outside
director or a director not engaged in the day-to-day management of a
broker or dealer;
    (2) is an officer, director (excluding an outside director), or
employee of an entity that owns more than ten percent of the equity of
a broker or dealer, and the broker or dealer accounts for more than
five percent of the gross revenues received by the consolidated entity;
    (3) owns more than five percent of the equity securities of any
broker or dealer, whose investments in brokers or dealers exceed ten
percent of his or her net worth, or whose ownership interest otherwise
permits him or her to be engaged in the day-to-day management of a
broker or dealer;
    (4) provides professional services to brokers or dealers, and such
services constitute 20 percent or more of the professional revenues
received by the Director or 20 percent or more of the gross revenues
received by the Director's firm or partnership;
    (5) provides professional services to a director, officer, or
employee of a broker, dealer, or corporation that owns 50 percent or
more of the voting stock of a broker or dealer, and such services
relate to the director's, officer's, or employee's professional
capacity and constitute 20 percent or more of the professional revenues
received by the Director or 20 percent or more of the gross revenues
received by the Director's firm or partnership; or
    (6) has a consulting or employment relationship with or provides
professional services to the Corporation or any affiliate \7\ thereof
(including any Self-Regulatory Subsidiary) or to the Financial Industry
Regulatory Authority (``FINRA'') (or any predecessor) or has had any
such relationship or provided any such services at any time within the
prior three years.
---------------------------------------------------------------------------

    \7\ NASDAQ OMX is adding a definition of ``affiliate'' as
follows: ``An `affiliate' of, or a person `affiliated' with, a
specified person, is a person that directly, or indirectly through
one or more intermediaries, controls, or is controlled by, or is
under common control with, the person specified.'' The definition is
identical to the definition of the term in SEC Rule 12b-2, 17 CFR
240.12b-2.
---------------------------------------------------------------------------

    Thus, the current definition focuses on a Director's affiliation
with any broker-dealer, regardless of whether the broker-dealer is a
member or member organization of a Self-Regulatory Subsidiary. The
definition also features a three-year ``look-back'' period during which
a Director formerly associated with a broker-dealer would continue to

be deemed an Industry Director. In lieu of this definition, NASDAQ OMX
is proposing to adopt a definition that focuses on whether a Director
is affiliated with a member or a member organization of a Self-
Regulatory Subsidiary. Under the revised definition, an Industry
Director will be defined as a Director who:
    (1) Is, or within the last year was, or has an immediate family
member \8\ who is, or within the last year was, a member of a Self-
Regulatory Subsidiary; \9\
---------------------------------------------------------------------------

    \8\ NASDAQ OMX is adding a definition of ``immediate family
member'' as follows: '' `Immediate family member' means a person's
spouse, parents, children and siblings, whether by blood, marriage
or adoption, or anyone residing in such person's home.'' The
definition is identical to the definition of ``family member''
contained in NASDAQ listing standards, as provided in NASDAQ Rule
5605.
    \9\ This provision would apply to an individual that was a
member of Phlx, the only Self-Regulatory Subsidiary that allows
natural persons to become members.
---------------------------------------------------------------------------

    (2) is, or within the last year was, employed by a member or a
member organization of a Self-Regulatory Subsidiary; \10\
---------------------------------------------------------------------------

    \10\ A broker-dealer that is admitted to membership in Phlx is
referred to as a ``member organization;'' broker-dealers admitted to
membership in the other Self-Regulatory Subsidiaries are referred to
as ``members.''
---------------------------------------------------------------------------

    (3) has an immediate family member who is, or within the last year
was, an executive officer of a member or a member organization \11\ of
a Self-Regulatory Subsidiary;
---------------------------------------------------------------------------

    \11\ An ``Executive Officer'' of a member or member organization
means those officers covered in Rule 16a-1(f) under the Act, as if
the member or member organization were an issuer within the meaning
of such Rule. 17 CFR 240.16a-1(f).
---------------------------------------------------------------------------

    (4) has within the last year received from any member or member
organization of a Self-Regulatory Subsidiary more than $100,000 per
year in direct compensation, or received from such members or member
organizations in the aggregate an amount of direct compensation that in
any one year is more than 10 percent of the Director's annual gross
compensation for such year, excluding in each case director and
committee fees and pension or other forms of deferred compensation for
prior service (provided such compensation is not contingent in any way
on continued service); or
    (5) is affiliated, directly or indirectly, with a member or member
organization of a Self-Regulatory Subsidiary.
    NASDAQ OMX believes that the change is warranted to ensure that the
definition of Industry Director is appropriately focused on the
mitigation of potential conflicts of interest associated with Directors
who are currently or were very recently employed by members or member
organizations of Self-Regulatory Subsidiaries, or that otherwise have
material affiliations with such members or member organizations. The
current definition covers individuals who are employed by broker-
dealers that are not members of Self-Regulatory Subsidiaries, or who
retired from service at a broker-dealer more than one, but less than
three years in the past. NASDAQ OMX and the Exchange believe that by
deeming such potential Directors to be Industry Directors, the current
By-Laws unnecessarily restrict highly qualified individuals with
extensive knowledge of the financial services industry from serving on
the Board.
    In addition to this change, NASDAQ OMX is also proposing the
following additional changes to the definitions applicable to
categories of Directors:
    (1) NASDAQ OMX proposes a new definition of ``Staff Director.''
Currently, the definition of ``Staff Director'' is included within the
definition of ``Industry Director,'' and is defined as ``any two
officers of the Corporation, selected at the sole discretion of the
Board, amongst those officers who may be serving as Directors.'' By
virtue of being designated as Staff Directors, these Directors are not
considered to be Industry Directors for purposes of the compositional
requirements of the By-Laws. Instead, NASDAQ OMX proposes a separate
definition of ``Staff Director'' as ``an officer of the Corporation
that is serving as a Director.'' \12\ As discussed below, however,
Section 4.3 of the By-Laws is to be amended to provide that only one
Staff Director may serve on the Board, unless the Board consists of ten
or more Directors, in which case no more than two Staff Directors may
serve. Thus, the change will further restrict the number of possible
Staff Directors in instances where the Board is smaller than ten
Directors, while retaining the current limit for a larger Board.
---------------------------------------------------------------------------

    \12\ The definition of ``Industry Director'' will continue to
exclude Staff Directors, who might otherwise be considered Industry
Directors by virtue of affiliation with NASDAQ Exchange Services LLC
and NASDAQ Options Services, LLC, registered broker-dealers that are
members or NASDAQ and BX and member organizations of Phlx.
---------------------------------------------------------------------------

    (2) NASDAQ OMX is adopting a new definition of ``Issuer Director''
and ``Issuer committee member''. The By-Laws currently provide that the
number of ``Non-Industry Directors'' (i.e., Directors who are not
Industry Directors) must equal or exceed the number of Industry
Directors, and shall include at least one ``issuer representative,''
unless the Board consists of ten or more Directors, in which case it
must include at least two issuer representatives. NASDAQ OMX and the
Exchange believe that requiring the representation of issuers on the
Board is consistent with the goal of promoting a diversity of
viewpoints and skills among Directors and the requirement of Section
6(b)(3) of the Act \13\ to provide for representation of issuers among
the directors of a national securities exchange. The term ``issuer
representative'' is not directly defined in the By-Laws, but is
implicitly defined in the definition of ``Non-Industry Director'' as
``an officer, director, or employee of an issuer of securities listed
on a national securities exchange operated by any Self-Regulatory
Subsidiary.'' The new proposed definition is ``a Director (excluding
any Staff Director) or committee member who is an officer or employee
of an issuer of securities listed on a national securities exchange
operated by any Self-Regulatory Subsidiary, excluding any Director or
committee member who is a director of such an issuer but is not also an
officer or employee of such an issuer.'' The exclusion of Staff
Directors from the definition is necessary because NASDAQ OMX is listed
on NASDAQ, but the purposes of the By-Laws in requiring issuer
representation to promote a diversity of viewpoints among Directors
would not be well served by deeming Staff Directors also to be Issuer
Directors. The definition is also being changed to exclude persons who
are directors of issuers but not also officers or employees. This
change is intended to make it clear that a Director is not barred from
being considered a Public Director \14\ merely because the Director
serves as an independent director of another listed company.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(3).
    \14\ The definition of Public Director is discussed below.
---------------------------------------------------------------------------

    (3) The definition of ``Public Director'' and ``Public committee
member'' is being restated as follows: ``a Director or committee member
who (1) is not an Industry Director or Industry committee member, (2)
is not an Issuer Director or Issuer committee member, and (3) has no
material business relationship with a member or member organization of
a Self-Regulatory Subsidiary, the Corporation or its affiliates, or
FINRA.'' The definition currently covers a person who ``has no material
business relationship with a broker or dealer, the Corporation or its
affiliates, or FINRA.'' Thus, the changes make it clear that any
Industry Director or Issuer Director would not be considered a Public
Director. As noted above, however, an

independent director of an issuer of securities listed on NASDAQ could
be considered a Public Director. In addition, in keeping with the
change to the definition of Industry Director discussed above, the
final clause of the definition is being revised to focus on the
existence of a material business relationship with a member or member
organization of a Self-Regulatory Subsidiary, rather than any broker or
dealer. Thus, for example, a Director that had a material business
relationship with a non-U.S. broker or dealer that was not a member or
a member organization of a Self-Regulatory Subsidiary might be eligible
to be a Public Director.
    (4) The definition of ``Non-Industry Director'' or ``Non-Industry
committee member'' is proposed to be amended to cover any ``Director
(excluding any Staff Director) or committee member who is (1) a Public
Director or Public committee member; (2) an Issuer Director or Issuer
committee member; or (3) any other individual who would not be an
Industry Director or Industry committee member.'' The revised
definition is generally consistent with the current definition, but
reflects the adoption of a definition for ``Issuer Director or Issuer
committee member''.
    (5) NASDAQ OMX is making conforming changes to the letter
designations of paragraphs in Article I of the By-Laws.
Qualifications of Directors
    NASDAQ OMX is proposing to amend Section 4.3 of the By-Laws, which
governs the qualifications and compositional requirements of the Board
of Directors, to (i) increase the required number of Public Directors
from one to two, (ii) replace the requirement to include at least one
issuer representative (or at least two issuer representatives if the
Board consists of ten or more Directors) with a requirement to include
at least one, but no more than two, Issuer Directors, and (iii) provide
that the number of Staff Directors may not exceed one, unless the Board
consists of ten or more Directors, in which case the number may not
exceed two. The section will continue to require that the number of
Non-Industry Directors equals or exceeds the number of Industry
Directors. Although these changes will not significantly modify the
Board's compositional requirements, they will continue to ensure a
diversity of representation among Industry, Staff, Issuer, and Public
Directors, will place more stringent caps on the number of Issuer and
Staff Directors, and will increase the requirement for Public
Directors. NASDAQ OMX also proposes to make a conforming change to add
the term ``Issuer Director'' to Section 4.8 and Section 4.13(h), which
govern the filling of vacancies on the Board and the determination of
Directors' qualifications by NASDAQ OMX's Secretary.
    The changes to the compositional requirements imposed specifically
by the By-Laws do not alter in any respect the compositional
requirements imposed by NASDAQ listing standards on NASDAQ OMX as a
public company. Specifically, NASDAQ Rule 5605 requires that the board
of directors of a company listed on NASDAQ must have a majority of
directors that are ``independent'' within the meaning of that rule. As
provided in NASDAQ Rule 5605(a)(2) with respect to a company listed on
NASDAQ (a ``Company''), '' `Independent Director' means a person other
than an Executive Officer \15\ or employee of the Company or any other
individual having a relationship which, in the opinion of the Company's
board of directors, would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director.'' The rule
goes on to provide that directors having certain defined relationships
with a Company may not be considered independent. Thus, while Staff
Directors are clearly not independent within the meaning of Rule 5605,
other Directors may or may not be considered independent, depending on
the specific facts of their relationship to NASDAQ OMX. The proposed
rule change does not alter in any respect the obligations of the NASDAQ
OMX Board under NASDAQ Rule 5605.
---------------------------------------------------------------------------

    \15\ NASDAQ Rule 5605(a)(1) provides that '' `Executive Officer'
means those officers covered in Rule 16a-1(f) under the Act.'' 17
CFR 240.16a-1(f).
---------------------------------------------------------------------------

Composition of Executive Committee
    NASDAQ OMX is proposing a minor amendment to the compositional
requirements of its Executive Committee. Currently, Section 4.13(d) of
the By-Laws provides that the percentage of Public Directors on the
Executive Committee must be at least as great as the percentage of
Public Directors on the whole Board. As noted above, however, the By-
Laws currently require only one Public Director on the whole Board (a
requirement that NASDAQ OMX is proposing to raise to two Public
Directors). Thus, the By-Laws currently reflect a standard under which
voluntary inclusion of additional Public Directors on the full Board
translates into a requirement to include ever increasing numbers of
Public Directors on the Executive Committee, even though the
requirements for the full Board itself may be satisfied with only one
Public Director. Accordingly, NASDAQ OMX is proposing to make the
requirements consistent by requiring at least two Public Directors on
the Executive Committee.
Composition of the Audit Committee
    Earlier this year, the Commission approved changes to the
provisions of NASDAQ OMX's By-Laws pertaining to the composition of the
Management Compensation Committee of its Board of Directors. NASDAQ OMX
is now proposing comparable changes to the compositional requirements
of its Audit Committee. Specifically, NASDAQ OMX is proposing to amend
Section 4.13(g) to replace a requirement that the Audit Committee be
composed of a majority of Non-Industry Directors with a requirement
that the number of Non-Industry Directors on the committee equal or
exceed the number of Industry Directors. Thus, in the case of a
committee composed of four Directors, the current By-Law provides that
only one Director may be an Industry Director, while the amended By-Law
would allow up to two Directors to be Industry Directors. The proposed
compositional requirement for the committee with regard to the balance
between Industry Directors and Non-Industry Directors would be the same
as that already provided for in the By-Laws with respect to the
Executive Committee, the Nominating and Governance Committee, the
Management Compensation Committee, and the full Board of Directors.
    NASDAQ OMX and the Exchange believe that the change will provide
greater flexibility to NASDAQ OMX with regard to populating a committee
that includes Directors with relevant expertise and that is not
excessively large in relation to the size of the full Board of
Directors, while continuing to ensure that Directors associated with
members and member organizations of the Self-Regulatory Subsidiaries do
not exert disproportionate influence of the governance of NASDAQ OMX.
As required by Section 10A of the Act,\16\ SEC Rule 10A-3
thereunder,\17\ and NASDAQ Rule 5605(c), the committee would continue
at all times to be composed solely of Directors who are independent
within the meaning of those provisions.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78j-1.
    \17\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

2. Statutory Basis
    Phlx believes that the proposed rule change is consistent with the
provisions

of Section 6 of the Act,\18\ in general, and with Sections 6(b)(1) and
(b)(5) of the Act,\19\ in particular, in that the proposal enables Phlx
to be so organized and to have the capacity to be able to carry out the
purposes of the Act and to comply with and enforce compliance by
members and persons associated with members with provisions of the Act,
the rules and regulations thereunder, and Phlx rules, and is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, 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.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f.
    \19\ 15 U.S.C. 78f(b)(1), (5).
---------------------------------------------------------------------------

    In particular, Phlx believes that the change to the definition of
Industry Director is warranted to ensure that it is appropriately
focused on the mitigation of potential conflicts of interest associated
with Directors who are currently or were very recently employed by
members or member organizations of Self-Regulatory Subsidiaries, or
that otherwise have material affiliations with such members or member
organizations, without unnecessarily restricting highly qualified
individuals with extensive knowledge of the financial services industry
from serving on the Board. Phlx further believes that the other
definitional changes and the changes to the compositional requirements
of the NASDAQ OMX Board and the Executive Committee will enhance the
clarity of these provisions and promote a diversity of backgrounds and
viewpoints on the NASDAQ OMX Board. The Exchange believes that these
changes will collectively promote the capacity of the NASDAQ OMX Board
to fulfill its responsibilities.
    With respect to the proposed changes to the Audit Committee's
compositional requirements, Phlx believes that the change will provide
greater flexibility to NASDAQ OMX with regard to populating a committee
that includes Directors with relevant expertise and that is not
excessively large in relation to the size of the full Board of
Directors, while continuing to ensure that Directors associated with
members and member organizations of Self-Regulatory Subsidiaries do not
exert disproportionate influence of the governance of NASDAQ OMX. The
change would not affect NASDAQ OMX's compliance with Section 10A of the
Act,\20\ SEC Rule 10A-3 thereunder,\21\ and NASDAQ Rule 5605(c), as the
committee would continue at all times to be composed solely of
Directors who are independent within the meaning of those provisions.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78j-1.
    \21\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

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 [sic] the Act. Specifically, the Exchange
believes that the By-Laws of its holding company, NASDAQ OMX, do not
directly affect competition between the Exchange and others that
provide the same goods and services as the Exchange, since they do not
affect the availability or pricing of such goods and services. To the
extent that the proposed change to the By-Laws may be construed to have
any bearing on competition, the Exchange believes that the change will
promote competition between the Exchange and the subsidiaries of NYSE
Euronext, since the change will allow NASDAQ OMX to have greater
flexibility in the selection of its Directors in a manner similar to
the flexibility available to NYSE Euronext under its Independence
Policy.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) by order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be 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-Phlx-2012-142 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-Phlx-2012-142. 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 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal offices 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-
Phlx-2012-142, and should be submitted on or before January 22, 2013.
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-31238 Filed 12-28-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Proposed Rules]
[Pages 60667-60670]
[FR Doc No: 2012-23991]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

48 CFR Part 1552

[EPA-HQ-OARM-2012-0196]

EPAAR Clause for Printing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) amends the EPA
Acquisition Regulation (EPAAR) to update policy, procedures, and
contract clauses. The proposed rule provides updates to outdated
information currently in the Printing clause.

DATES: Comments must be received on or before November 5, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2012-0196, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: EPA-HQ-OARM-2012-0196, OEI Docket, Environmental
Protection Agency, 2822T, 1200 Pennsylvania Ave.

NW., Washington, DC 20460. Please include a total of three (3) copies.
     Hand Delivery: EPA Docket Center-Attention OEI Docket, EPA
West, Room B102, 1301 Constitution Ave. NW., Washington, DC 20004. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OARM-
2012-0196. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket, and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment, and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties, and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov, or in hard copy at the Office of Environmental
Information (OEI) Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The 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 Public Reading Room is (202)
566-1744, and the telephone number for the EPA Docket Center is (202)
566-1752. This Docket Facility is open from 8:30 a.m. to 4:30 p.m.
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy, Training,
and Oversight Division, Office of Acquisition Management (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI, and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    In 2011 the EPA reviewed EPAAR clause 1552.208-70, Printing. Review
was performed to reconsider the electronic reproduction threshold under
which vendors may provide contract deliverables without violating
mandatory printing source requirements. Reconsideration of the
reproduction threshold was warranted given the ease with which
electronic media may be reproduced. The clause is also being updated to
clarify that EPA's Print Management Team is the processing office
responsible for clause printing requirement waivers provided by the
Joint Committee on Printing. Finally, the definition of non-paper
copies that the contractor may provide has been expanded to include
other types of portable electronic media in addition to compact discs.
As such, the proposed updates to the clause raise the limit for
contractor-provided non-paper copies from 100 to 500, and clarifies
that EPA's Print Management Team is the processing office responsible
for clause printing requirement waivers.

III. Proposed Rule

    This proposed rule amends the EPAAR to revise the following within
the Printing clause:
    1. Paragraph (d)(2)--changed from ``the contracting officer must
obtain a waiver from the U.S. Congress Joint Committee on Printing'' to
``Only the Joint Committee on Printing has the authority to grant
waivers to the printing requirements. All Agency waiver requests must
be coordinated with EPA's Headquarters Printing Management Team,
Facilities and Services Division, and with the Office of General
Counsel.''
    2. Paragraph (d)(3)--changed from ``the contracting officer must
obtain a waiver from the U.S. Congress Joint Committee on Printing'' to
``Only the Joint Committee on Printing has the authority to grant
waivers to the printing requirements. All Agency waiver requests must
be coordinated with EPA's Headquarters Printing Management Team,
Facilities and Services Division, and with the Office of General
Counsel.''
    3. Paragraph (d)(4)--changed from ``the contracting officer must
obtain a waiver from the U.S. Congress Joint Committee on Printing'' to
``Only the Joint Committee on Printing has the

authority to grant waivers to the printing requirements. All Agency
waiver requests must be coordinated with EPA's Headquarters Printing
Management Team, Facilities and Services Division, and with the Office
of General Counsel.''
    4. Paragraph (d)(4)--duplication limit changed from 100 to 500.
    5. Paragraph (d)(4)--examples of non-paper duplication expanded
from ``CDs/DVDs'' to ``electronic information storage device.''

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
therefore, not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
No information is collected under this action.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute; unless the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's final rule on small
entities, ``small entity'' is defined as: (1) A small business that
meets the definition of a small business found in the Small Business
Act and codified at 13 CFR 121.201; (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This action
revises a current EPAAR provision and does not impose requirements
involving capital investment, implementing procedures, or
recordkeeping. This rule will not have a significant economic impact on
small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Local, and Tribal
governments and the private sector.
    This rule contains no Federal mandates (under the regulatory
provisions of the Title II of the UMRA) for State, Local, and Tribal
governments or the private sector. The rule imposes no enforceable duty
on any State, Local or Tribal governments or the private sector. Thus,
the rule is not subject to the requirements of Sections 202 and 205 of
the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and Local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.''
    This rule does not have federalism implications. It will not have
substantial direct effects 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 as
specified in Executive Order 13132.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Goverments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications as specified in Executive Order 13175.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, entitled ``Protection of Children from
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under Executive Order 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to Executive Order 13045
because it is not an economically significant rule as defined by
Executive Order 12866, and because it does not involve decisions on
environmental health or safety risks.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution of Use'' (66 FR 28335, May 22, 2001), because it
is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    Section 12(d) (15 U.S.C. 272 note) of NTTA, Public Law 104-113,
directs EPA to use voluntary consensus standards in it's regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to

make environmental justice part of their mission by identifying and
addressing, as appropriate, disproportionately high and adverse human
health or environmental effects of their programs, policies, and
activities on minority populations and low-income populations in the
United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This proposed rulemaking does not involve human health or
environmental affects.

List of Subjects in 48 CFR Part 1552

    Environmental Protection, Required Sources of Supply, Printing.

    Dated: September 18, 2012.
John R. Bashista,
Director, Office of Acquisition Management.

    Therefore, 48 CFR Chapter 15 is proposed to be amended as set forth
below:

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

    1. The authority citation for part 1552 continues to read as
follows:

    Authority:  5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended,
40 U.S.C. 486(c); and 41 U.S.C. 418b.

    2. Revise 1552.208-70 to read as follows:

1552.208-70   Printing.

    As prescribed in 1508.870, insert the following clause:

Printing (SEP 2012)

    (a) Definitions. ``Printing'' is the process of composition,
plate making, presswork, binding and microform; or the end items
produced by such processes and equipment. Printing services include
newsletter production and periodicals which are prohibited under EPA
contracts.
    ``Composition'' applies to the setting of type by hot-metal
casting, photo typesetting, or electronic character generating
devices for the purpose of producing camera copy, negatives, a plate
or image to be used in the production of printing or microform.
    ``Camera copy'' (or ``camera-ready copy'') is a final document
suitable for printing/duplication.
    ``Desktop Publishing'' is a method of composition using
computers with the final output or generation of a camera copy done
by a color inkjet or color laser printer. This is not considered
``printing.'' However, if the output from desktop publishing is
being sent to a typesetting device (i.e., Linotronic) with camera
copy being produced in either paper or negative format, these
services are considered ``printing.''
    ``Microform'' is any product produced in a miniaturized image
format, for mass or general distribution and as a substitute for
conventionally printed material. Microform services are classified
as printing services and include microfiche and microfilm. The
contractor may make up to two sets of microform files for archival
purposes at the end of the contract period of performance.
    ``Duplication'' means the making of copies on photocopy machines
employing electrostatic, thermal, or other processes without using
an intermediary such as a negative or plate.
    ``Requirement'' means an individual photocopying task. (There
may be multiple requirements under a Work Assignment or Delivery
Order. Each requirement would be subject to the duplication
limitation of 5,000 copies of one page or 25,000 copies of multiple
pages in the aggregate per requirement).
    ``Incidental'' means a draft and/or proofed document (not a
final document) that is not prohibited from printing under EPA
contracts.
    (b) Prohibition. (1) The contractor shall not engage in, nor
subcontract for, any printing in connection with the performance of
work under this contract. Duplication of more than 5,000 copies of
one page or more than 25,000 copies of multiple pages in the
aggregate per requirement constitutes printing. The intent of the
printing limitation is to eliminate duplication of final documents.
    (2) In compliance with EPA Order 2200.4a, EPA Publication Review
Procedure, the Office of Communications, Education, and Media
Relations is responsible for the review of materials generated under
a contract published or issued by the Agency under a contract
intended for release to the public.
    (c) Affirmative Requirements. (1) Unless otherwise directed by
the contracting officer, the contractor shall use double-sided
copying to produce any progress report, draft report or final
report.
    (2) Unless otherwise directed by the contracting officer, the
contractor shall use recycled paper for reports delivered to the
Agency which meet the minimum content standards for paper and paper
products as set forth in EPA's Web site for the Comprehensive
Procurement Guidelines at: http://www.epa.gov/cpg/.
    (d) Permitted Contractor Activities. (1) The prohibitions
contained in paragraph (b) do not preclude writing, editing, or
preparing manuscript copy, or preparing related illustrative
material to a final document (camera-ready copy) using desktop
publishing.
    (2) The contractor may perform a requirement involving the
duplication of less than 5,000 copies of only one page, or less than
25,000 copies of multiple pages in the aggregate, using one color
(black), such pages shall not exceed the maximum image size of 10\3/
4\ by 14\1/4\ inches, or 11 by 17 paper stock. Duplication services
below these thresholds are not considered printing. If performance
of the contract will require duplication in excess of these
thresholds, contractors must immediately notify the contracting
officer in writing and a waiver must be obtained. Only the Joint
Committee on Printing has the authority to grant waivers to the
printing requirements. All Agency waiver requests must be
coordinated with EPA's Headquarters Printing Management Team,
Facilities and Services Division, and with the Office of General
Counsel. Duplication services of ``incidentals'' in excess of the
thresholds are allowable.
    (3) The contractor may perform a requirement involving the
multi-color duplication of no more than 100 pages in the aggregate
using color copier technology, such pages shall not exceed the
maximum image size of 10\3/4\ by 14\1/4\ inches, or 11 by 17 paper
stock. Duplication services below these thresholds are not
considered printing. If performance of the contract will require
duplication in excess of these limits, contractors must immediately
notify the contracting officer in writing and a waiver must be
obtained. Only the Joint Committee on Printing has the authority to
grant waivers to the printing requirements. All Agency waiver
requests must be coordinated with EPA's Headquarters Printing
Management Team, Facilities and Services Division, and with the
Office of General Counsel.
    (4) The contractor may perform the duplication of no more than a
total of 500 units of an electronic information storage device
(e.g., CD-ROMs, DVDs, thumb drives*) (including labeling and
packaging) per work assignment or task order/delivery order per
contract year. Duplication services below these thresholds are not
considered printing. If performance of the contract will require
duplication in excess of these thresholds, contractors must
immediately notify the contracting officer in writing and a waiver
must be obtained. Only the Joint Committee on Printing has the
authority to grant waivers to the printing requirements. All Agency
waiver requests must be coordinated with EPA's Headquarters Printing
Management Team, Facilities and Services Division, and with the
Office of General Counsel.
    (e) Violations. The contractor may not engage in, nor
subcontract for, any printing in connection with the performance of
work under the contract. The cost of any printing services in
violation of this clause will be disallowed, or not accepted by the
Government.
    (f) Flowdown Clause. The contractor shall include in each
subcontract which may involve a requirement for any printing/
duplicating/copying a provision substantially the same as this
clause.
    * Pursuant to the July 2008 guidance Promotional Communications
for EPA, a thumb drive can be used as a promotional item, but it
also must be an information medium in itself. Namely, it must have
substantive EPA information already loaded into the drive. Due to
its intrinsic material value, it may not be used simply or primarily
to display an EPA message on the exterior of the drive.

(End of clause)

[FR Doc. 2012-23991 Filed 10-3-12; 8:45 am]
BILLING CODE 6560-50-P