[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Notices]
[Page 37281-37282]
[DOCID:fr09jy07-122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55997; File No. PCAOB-2007-01]

Public Company Accounting Oversight Board; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Adjusting
Implementation Schedule of Rule 3523, Tax Services for Persons in
Financial Reporting Oversight Roles

July 2, 2007.
    Pursuant to section 107(b) of the Sarbanes-Oxley Act of 2002 (the
``Act''), notice is hereby given that on April 3, 2007, the Public
Company Accounting Oversight Board (the ``Board'' or the ``PCAOB'')
filed with the Securities and Exchange Commission (the ``SEC'' or
``Commission'') the proposed rule change described in Items I and II
below, which items have been prepared by the Board. The PCAOB has
designated the proposed rule change as ``constituting a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule'' under Section
19(b)(3)(A)(i) of the Securities Exchange Act of 1934 (as incorporated,
by reference, into Section 107(b)(4) of the Act), which renders the
proposal effective upon receipt of this filing by the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule from interested persons.

I. Board's Statement of the Terms of Substance of the Proposed Rule

    The PCAOB is filing with the SEC an adjustment of the
implementation schedule for Rule 3523, Tax Services for Persons in
Financial Reporting Oversight Roles. Specifically the Board will not
apply Rule 3523 to tax services provided on or before July 31, 2007,
when those services are provided during the audit period and are
completed before the professional engagement period begins. The PCAOB
is not proposing any textual changes to the Rules of the PCAOB.

II. Board's Statement of the Purpose of, and Statutory Basis for, the
Proposed Rule

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

A. Board's Statement of the Purpose of, and Statutory Basis for, the
Proposed Rule

(a) Purpose
    On July 26, 2005, the Board adopted certain rules related to
registered public accounting firms' provision of tax services to public
company audit clients. The rules were designed to address certain
concerns related to auditor independence when auditors sell personal
tax services to individuals who play a direct role in preparing the
financial statements of public company audit clients or market or
otherwise opine in favor of aggressive tax shelter schemes. As part of
this rulemaking, the Board adopted Rule 3523, which provides that a
registered firm, subject to certain exceptions, is not independent of
an audit client if the firm, or an affiliate of the firm, provides tax
services during the audit and professional engagement period\1\ to a
person in, or an immediate family member of a person in, a financial
reporting oversight role at an audit client. Rule 3523 was approved by
the Securities and Exchange Commission (``SEC'') on April 19, 2006.
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    \1\ Consistent with the SEC's independence rules, 17 CFR 210.2-
01(f)(5), the phrase ``audit and professional engagement period'' is
defined to include two discrete periods of time. The ``audit
period'' is the period covered by any financial statements being
audited or reviewed. Rule 3501(a)(iii)(1). The ``professional
engagement period'' is the period beginning when the accounting firm
either signs the initial engagement letter or begins audit
procedures and ends when the audit client or the accounting firm
notifies the SEC that the client is no longer that firm's audit
client. Rule 3501(a)(iii)(2).
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    On October 31, 2006, the Board adjusted the implementation schedule
for Rule 3523, as it applies to tax services provided during the period
subject to audit but before the professional engagement period, so that
the Board could revisit this aspect of the

rule.\2\ On April 3, 2007, the Board issued a concept release to
solicit comment on the possible effects on a firm's independence of
providing tax services to a person covered by Rule 3523 during the
portion of the audit period that precedes the beginning of the
professional engagement period, and other practical consequences of
applying the restrictions imposed by Rule 3523 to that portion of the
audit period. The Board has determined to further adjust the
implementation schedule for Rule 3523 in order to allow sufficient time
for consideration of commenters' views. Specifically, the Board will
not apply Rule 3523 to tax services provided on or before July 31,
2007, when those services are provided during the audit period and are
completed before the professional engagement period begins.
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    \2\ See PCAOB Release No. 2006-006 (October 31, 2006), at 2.
Specifically, the Board stated that Rule 3523 will not apply to tax
services provided on or before April 30, 2007, when those services
are provided during the audit period and are completed before the
professional engagement period begins.
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    No other aspect of the Board's rules on independence and tax
services is affected by this extension. As of November 1, 2006,
registered firms have been required to comply with Rule 3523 as it
relates to tax services provided while they serve as auditor of record
for an audit client--that is, during the ``professional engagement
period.'' In addition, with one exception, all other PCAOB rules
concerning independence, tax services, and contingent fees that were
adopted by the Board on July 26, 2005 and approved by the SEC on April
19, 2006 are now in effect.\3\
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    \3\ With respect to tax services provided to audit clients whose
audit committees pre-approve tax services pursuant to policies and
procedures, Rule 3524 will not apply to any such tax service that is
begun by April 20, 2007. See PCAOB Release No. 2006-001 (March 28,
2006), at 2-3, PCAOB Release No. 2005-020 (November 22, 2005) at 2-
3, and PCAOB Release No. 2005-14 (July 26, 2005) at 47-48.
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(b) Statutory Basis
    The statutory basis for the proposed rule change is Title I of the
Act.

B. Board's Statement on Burden on Competition

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

C. Board's Statement on Comments on the Proposed Rule Received From
Members, Participants or Others

    The Board did not solicit or receive written comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Securities Exchange Act of 1934 (as incorporated, by
reference, into Section 107(b)(4) of the Act) and paragraph (f) of Rule
19b-4 thereunder. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
is consistent with the requirements of Title I of 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/pcaob.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number PCAOB-2007-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number PCAOB-2007-01. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/pcaob.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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the PCAOB. All comments received will be posted
without change; we do 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 PCAOB-
2007-01 and should be submitted on or before July 30, 2007.

    By the Commission.
Nancy M. Morris,
Secretary.
[FR Doc. E7-13136 Filed 7-6-07; 8:45 am]

BILLING CODE 8010-01-P


23 The previous 2A/ 2S ICR estimated a combined State and Agency burden. As such, this table details State burden as specified in the 1995 applications ICR for Standard Form A, Short Form A, Section 308 Requests, and Interim Sewage Sludge Permit Application Form.

Applications ICR 8/ 5/ 99 62 Construction 12,674 022 12,674 Program 22 MSGP ( Industrial  stormwater) 3,428 022 3,428 Program 22 Applicant Respondent Subtotal: 1,947,402 504,416 1,442,986 Applicant Respondent Total: 1,990,775 520,736 1,470,039 Exhibit 28. Change in State Respondent Burden Information Collection Activity Burden Current ICR Burden Previous ICR Change ( hours) Type of Change Form 1: 6,102 5,625 477 Adjustment Form 2A: 23 7,910 1,322 6,588 Adjustment Sec. 308 Requests  Municipals: 454 2,346 ( 1,892) Adjustment Form 2B: 62 223 ( 161) Adjustment Form 2C: 15,080 9,544 5,536 Adjustment Form 2D: 0 0 0

Sec. 308 Requests  Non Municipal: 594 787 ( 193) Adjustment Form 2E: 2,094 1,309 785 Adjustment Form 2F: 121 112 9 Adjustment Form 2S: 23 422 5,351 ( 4,929)

NOI Stormwater and NOI: 4,189 8,980 ( 4,791) Adjustment Alaskan Lands: 0 0 0

MS4s: 1,754 380 1,374 Adjustment Petition for Individual Permit: 177 152 25 Adjustment Permit Consolidation: 46 38 8 Adjustment Notice of Construction: 0 0 0

Ocean Discharge: 2,437 2,024 413 Adjustment NOT: Information Collection Activity Burden Current ICR Burden Previous ICR Change ( hours) Type of Change 24 Not estimated in the previous ICR. In 1997, the construction general permit required NOTs be submitted where applicable. MSGPs' NOTs are optional ( see 60 FR 51122, IX. Termination of Coverage).

Applications ICR 8/ 5/ 99 63 Construction 5,097 024 5,097 Program24 MSGP ( Industrial  stormwater) 1,379 024 1,379 Program 24 State Respondent Total: 47,918 38,193 9,725 Applications ICR 8/ 5/ 99 64 Exhibit 29. Explanations for Substantial Changes in Applicant Respondent Burden Item/ Type of Applicant Respondent Source Explanation Recordkeeping Existing Facilities Applications ICR There has been an increase in the number of respondents reapplying NOI Stormwater's SWPPP Applications ICR The previous ICR did not estimate the recordkeeping burden associated with a SWPPP.

Form 1 Applications ICR/ PCS The previous ICR over estimated ( significantly) the number of facilities requesting an individual stormwater permit.

Form 2A Applications ICR/ PCS There has been an increase in the number of respondents.

Additional NPDES Application Requirements for Municipal Dischargers ( Section 308 Requests) Applications ICR/ PCS This ICR assumes some complex requests will be made.

Form 2B Applications ICR/ PCS There has been an estimated decrease in the number of respondents.

Form 2C Applications ICR/ PCS There has been an estimated increase in the number of respondents.

Additional NPDES Application Requirements for Non Municipal Dischargers ( Section 308 Requests) Applications ICR There has been a estimated decrease in the number of respondents.

Form 2E Applications ICR/ PCS There has been an estimated increase in number of respondents.

Form 2S Applications ICR/ Form 2A/ 2S ICR The estimate of the number of respondents is now more accurate.

NOI Stormwater and NOI Applications ICR The large increase is due to estimating the burden associated with developing a SWPPP. Note the previous ICR also included burden estimates for the construction NOI and baseline general permit for stormwater discharges from industrial activities NOI. The construction NOI is now covered under a separate ICR ( OMB Control No. 2040 0188) while the latter NOI no longer exists.

Application for Large and Medium MS4s Applications ICR An increase in the number of respondents reapplying are anticipated during the life of this ICR Applications ICR 8/ 5/ 99 65 6( f) Burden Statement The public reporting burden for collecting information is estimated to be an average of 22.1 hours per respondent. This estimate includes the time required to review the instructions, search existing data sources, gather and maintain all necessary data, and complete and review the information collection. The public recordkeeping burden is estimated to be an average of 1.3 hours per respondent.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose, 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 be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OP Regulatory Information Division, U. S. Environmental Protection Agency ( 2137), 401 M St., S. W., Washington D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence. 25 Note while Florida is delegated to issue general permits, EPA continues to administer the stormwater program.

Applications ICR 8/ 5/ 99 66 Appendix a: 1990 Census Data and State Delegation of NPDES, Sludge, and General Permit Programs State 1990 Population NPDES Delegation General Permit Delegation Sludge Delegation Alabama 4,040,587

Alaska 550,043 Arizona 3,665,228 Arkansas 2,350,725

California 29,760,021

CNMI 43,345 Colorado 3,294,394

Connecticut 3,287,116

Delaware 666,168

District of Columbia 606,900 Florida 12,937,926

25 Georgia 6,478,216

Guam 133,152 Hawaii 1,108,229

Idaho 1,006,749 Illinois 11,430,602

Indiana 5,544,159

Iowa 2,776,755

Kansas 2,477,574

Kentucky 3,685,296

Louisiana 4,219,973

Maine 1,227,928 Maryland 4,781,468

Massachusetts 6,016,425 Michigan 9,295,297

Minnesota 4,375,099

Mississippi 2,573,216

Missouri 5,117,073

Montana 799,065

Nebraska 1,578,385

Nevada 1,201,833

New Hampshire 1,109,252 New Jersey 7,730,188

New Mexico 1,515,069 New York 17,990,455

North Carolina 6,628,637

North Dakota 638,800

Ohio 10,847,115

Oklahoma 3,145,585

Oregon 2,842,321

Pennsylvania 11,881,643

Puerto Rico 3,522,037 Rhode Island 1,003,464

South Carolina 3,486,703

South Dakota 696,004

Tennessee 4,877,185

Texas 16,986,510

Utah 1,722,850

Vermont 562,758

Virginia 6,187,358

Virgin Islands 101,809

Washington 4,866,692

West Virginia 1,793,477

Wisconsin 4,891,769

Wyoming 453,588

Applications ICR 8/ 5/ 99 67 Total 252,510,216 233,114,088 216,025,769 21,854,945


To: John Schakenbach/DC/USEPA/US@EPA

From: Theresa Nguyen/DC/USEPA/US

Date: 08/30/2010 11:11AM

Subject: Re: Revised Substitute Data Percents

John,

I thought I sent this to you last week, but when checked my Sent box, it wasn't there.  Sorry.  Here it is.

PARAMETER CD	TOTAL OPERATING TIME WITH SUBSTITUTE DATA	TOTAL OPERATING TIME	TOTAL SUBSTITUTE OPERATING TIME / TOTAL OPERATING TIME

CO2C	37,727	7,725,372	0.5%

FLOW	71,547	6,584,739	1.1%

NOXC	35,208	12,231,074	0.3%

NOXR	116,005	11,903,499	1.0%

SO2C	74,487	6,028,639	1.2%

John Schakenbach---08/30/2010 11:06:28 AM---Thuy,

Thuy,

Any luck with the revised data substitution percents?  Last week we discussed that the substitute data operating time by parameter should be divided by the total operating time for all units having that parameter, instead of the total operating time for all units.

John Schakenbach

U.S. Environmental Protection Agency

Clean Air Markets Division

  HYPERLINK<EMAIL_ADDRESS>\t "blank"  <EMAIL_ADDRESS>

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>


Appendix I  2,4 D Aquatic Dissipation Data Spreadsheet I7  Farm Pond in North Carolina ( MRID 445250 01)

DAT BEE  Surface BEE  Subsurface BEE Avg Acid  Surface Acid  Subsurface Acid Avg LN Acid 0 1 1 1 248 29.4 139 4.93 Pond Area 0.3 acres 0 1 1 1 257 38.8 148 5.00 Treated Area 0.2 acres 0 1 1 1 216 76.8 146 4.99 Avg Depth 3 feet 0 3.9 42.2 23.1 457 23.8 240 5.48 Application Rate 38 lb ae/ acre 1 1 1 1 404 nd 404 6.00 Inflow Source None 1 1 1 1 460 59.5 260 5.56 1 1 1 1 424 248 336 5.82 Formulation Aquakleen 1 1 1 1 432 83 258 5.55 3 1 1 1 1110 131 621 6.43 LOQ 2 ppb 3 1 1 1 1030 165 598 6.39 3 1 1 1 1030 137 584 6.37 Half Life ( DAT 14 to 189) 52.1 days 3 1 1 1 945 97.6 521 6.26 7 1 1 1 1820 136 978 6.89 7 1 1 1 1890 154 1022 6.93 7 1 1 1 1980 174 1077 6.98 7 1 1 1 1660 151 906 6.81 14 1 1 1 3370 163 1767 7.48 14 1 1 1 2720 162 1441 7.27 14 1 1 1 2600 169 1385 7.23 14 1 1 1 2310 161 1236 7.12 30 1 1 1 1980 14.1 997 6.90 30 1 1 1 2000 13.3 1007 6.91 30 1 1 1 1320 10.1 665 6.50 30 1 1 1 2110 6.9 1058 6.96 59 1 1 1 473 963 718 6.58 59 1 1 1 828 1680 1254 7.13 59 1 1 1 870 850 860 6.76 59 1 1 1 ND 1020 1020 6.93 122 1 1 1 323 352 338 5.82 122 1 1 1 366 273 320 5.77 122 1 1 1 313 308 311 5.74 122 1 1 1 336 333 333 5.81 189 1 1 1 129 137 133 4.89 189 1 1 1 144 128 136 4.91 189 1 1 1 122 138 130 4.87 189 1 1 1 139 136 136 4.91 Avg 132 135 134 Max 3370 1680 0 0.2 0.4 0.6 0.8 1 Day After Treatment ( DAT) 0 0.2 0.4 0.6 0.8 1 2,4 D Concentration ( ppb) 2,4 D Accumulation and Dissipation ( DAT 0 to 30)

0 0.2 0.4 0.6 0.8 1 DAT 0 0.2 0.4 0.6 0.8 1 ln 2,4 D Concentration R square = 0.953 # pts = 20 y = 7.42 +  0.0133x 2,4 D Dissipation ( DAT 14 to 189)


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4216-4218]
[FR Doc No: 2018-01662]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-7001]

Qualified Infectious Disease Product Designation Questions and
Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Qualified
Infectious Disease Product Designation Questions and Answers.'' The
Food and Drug Administration Safety and Innovation Act (FDASIA) creates
incentives for the development of antibacterial and antifungal drug
products that treat serious or life-threatening infections. The purpose
of this draft guidance is to provide a resource for information on
FDA's policies and procedures related to the designation of a qualified
infectious disease product (QIDP).

DATES: Submit either electronic or written comments on the draft
guidance by April 2, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-7001 for ``Qualified Infectious Disease Product Designation
Questions and Answers; Draft Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For

more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Qualified Infectious Disease Product Designation Questions
and Answers.'' Title VIII of FDASIA created the Generating Antibiotic
Incentives Now (GAIN) provisions under section 505E of the Federal
Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355f). GAIN offers
incentives for the development of antibacterial and antifungal drugs
for human use to treat serious or life-threatening infections. The
primary incentive contained in GAIN is a 5-year extension of
exclusivity for which a QIDP-designated application qualifies upon
approval under the FD&C Act. QIDPs also receive fast track designation
at the sponsor's request (21 U.S.C. 356(b)(1)) and the first marketing
application submitted for approval of a QIDP is granted priority review
(21 U.S.C. 360n-1).
    This draft guidance provides information on the implementation of
GAIN and responses to common questions that might arise regarding QIDP
designation and review of QIDP new drug applications.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on qualified
infectious disease product designation questions and answers. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (PRA),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology.
    Title: Draft Guidance for Industry on Qualified Infectious Disease
Product Designation Questions and Answers.
    Description: As described in the draft guidance, a sponsor may
request a QIDP designation at any time prior to that sponsor's
submission of a marketing application under section 505(b) of the FD&C
Act (21 U.S.C. 355(b)) for that sponsor's drug product. A request for
QIDP designation should be submitted either to an investigational new
drug (IND) application or as pre-IND correspondence.
    The cover letter for the QIDP designation request should include
the following text in bold font at the top of the page: ``Request for
Qualified Infectious Disease Product Designation Questions and
Answers.'' Requests for multiple indications can be combined in a
single submission or made separately. The sponsor should clearly
identify each indication for which it is requesting QIDP designation.
    As described further in the draft guidance, each request should
include: (1) A discussion of the information that supports the role of
the drug as an antibacterial or antifungal drug, for example, in vitro
data, including any available data on mechanism of action; data from
animal models of infection; (2) any available human data from phase 1,
phase 2, or phase 3 studies; (3) the specific serious or life-
threatening indication(s) for which the sponsor intends (or has begun)
to develop the drug and the rationale or suitability for developing the
drug for the proposed serious or life-threatening infection(s); and (4)
the request may (but is not required to) include information to
demonstrate that the product is an antibacterial or antifungal drug
that has the capacity to treat a serious or life-threatening infection
caused by either of the following: resistant pathogen(s), including
novel or emerging infectious pathogens, and qualifying pathogens listed
in 21 CFR 317.2.
    We estimate that approximately 33 requests for QIDP designation, as
described in the draft guidance, will be submitted annually by
approximately 25 sponsors, and that it will take approximately 60 hours
to prepare and submit each request.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for a QIDP Designation....................................              25             1.32               33               60            1,980
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01662 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35944-35945]
[FR Doc No: 2017-16275]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0141; FRL-9963-30]

Certain New Chemicals or Significant New Uses; Statements of
Findings for April 2017

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA)
requires EPA to publish in the Federal Register a statement of its
findings after its review of TSCA section 5(a) notices when EPA makes a
finding that a new chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment. Such statements apply to premanufacture notices (PMNs),
microbial commercial activity notices (MCANs), and significant new use
notices (SNUNs) submitted to EPA under TSCA section 5. This document
presents statements of findings made by EPA on TSCA section 5(a)
notices during the period from April 1, 2017 to April 30, 2017.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Greg Schweer, Chemical Control Divison (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8469; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the PMNs addressed in this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0141, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 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 OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after
review of notices submitted under TSCA section 5(a) that certain new
chemical substances or significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. This
document presents statements of findings made by EPA during the period
from April 1, 2017 to April 30, 2017.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a)
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
chemical substance or significant new use;
     The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects and the
chemical substance or significant new use may present an unreasonable
risk of injury to health or the environment;
     The chemical substance is or will be produced in
substantial quantities, and such substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities or there is or may be significant or substantial human
exposure to the substance; or
     The chemical substance or significant new use is not
likely to

present an unreasonable risk of injury to health or the environment.
    Unreasonable risk findings must be made without consideration of
costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
under the conditions of use. The term ``conditions of use'' is defined
in TSCA section 3 to mean ``the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal
Register a statement of its findings after its review of a TSCA section
5(a) notice when EPA makes a finding that a new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment. Such statements apply to PMNs,
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new
chemical substance for a non-exempt commercial purpose and any
manufacturer or processor wishing to engage in a use of a chemical
substance designated by EPA as a significant new use must submit a
notice to EPA at least 90 days before commencing manufacture of the new
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding
of ``not likely to present an unreasonable risk of injury to health or
the environment'' may commence manufacture of the chemical substance or
manufacture or processing for the significant new use notwithstanding
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent
that such information is not claimed as Confidential Business
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this
period, EPA has made findings under TSCA section 5(a)(3)(C) that the
new chemical substances or significant new uses are not likely to
present an unreasonable risk of injury to health or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name, if the specific name is
claimed as CBI).
     Web site link to EPA's decision document describing the
basis of the ``not likely to present an unreasonable risk'' finding
made by EPA under TSCA section 5(a)(3)(C).
    EPA Case Number: J-17-0007; Chemical identity: Biofuel producing
Saccharomyces cerevisiae modified, genetically stable (generic name);
Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-54.
    EPA Case Number: P-17-0227; Chemical identity: 2-Alkenoic acid, 2-
alkyl-, alkyl ester, polymer with 2-alkyl 2-propenoate and -(2-alkyl-1-
oxo-2-alken-1-yl--alkoxypoly(oxy-1,2-alkanediyl), ester with -2-alken-
1-yl--hydroxypoly(oxy-1,2-alkanediyl); polymer exemption flag (generic
name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-53.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: June 8, 2017.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2017-16275 Filed 8-1-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Rules and Regulations]
[Pages 42592-42595]
[FR Doc No: 2017-19073]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31150; Amdt. No. 3761]

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 September 11, 2017. 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 September 11, 2017.

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: Thomas J. Nichols, 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 August 11, 2017.
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 14 September 2017

Colorado City, AZ, Colorado City Muni, NDB-A, Amdt 1
Colorado City, AZ, Colorado City Muni, RNAV (GPS) RWY 11, Orig
Colorado City, AZ, Colorado City Muni, RNAV (GPS) RWY 29, Orig
Phoenix, AZ, Phoenix-Mesa Gateway, RNAV (RNP) Z RWY 30C, Orig-B
Colusa, CA, Colusa County, GPS RWY 13, Orig-A, CANCELED
Colusa, CA, Colusa County, RNAV (GPS) RWY 31, Amdt 1
Colusa, CA, Colusa County, RNAV (GPS)-B, Orig
Colusa, CA, Colusa County, VOR-A, Amdt 5
Livermore, CA, Livermore Muni, ILS RWY 25R, Amdt 8
Livermore, CA, Livermore Muni, LOC RWY 25R, Orig
Ontario, CA, Ontario Intl, RNAV (GPS) Y RWY 26L, Amdt 2A
Vacaville, CA, Nut Tree, RNAV (GPS) RWY 20, Amdt 1
Monte Vista, CO, Monte Vista Muni, GPS RWY 20, Orig-A, CANCELED
Monte Vista, CO, Monte Vista Muni, RNAV (GPS) RWY 20, Orig
Monte Vista, CO, Monte Vista Muni, RNAV (GPS)-B, Amdt 1
Anderson, IN, Anderson Muni-Darlington Field, NDB RWY 30, Amdt 8
Kentland, IN, Kentland Muni, RNAV (GPS) RWY 27, Orig
Kentland, IN, Kentland Muni, Takeoff Minimums and Obstacle DP, Amdt
1
Grand Rapids, MI, Gerald R Ford Intl, ILS OR LOC RWY 8R, Amdt 6B
Grand Rapids, MI, Gerald R Ford Intl, ILS OR LOC RWY 26L, Amdt 21B
Grand Rapids, MI, Gerald R Ford Intl, ILS OR LOC RWY 35, ILS RWY 35
(SA CAT I), ILS RWY 35 (SA CAT II), Amdt 2
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 8L, Amdt 1A
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 8R, Amdt 1A
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 17, Amdt 1B
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 26L, Amdt 1A
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 26R, Amdt 1A
Grand Rapids, MI, Gerald R Ford Intl, RNAV (GPS) RWY 35, Amdt 1A
Staples, MN, Staples Muni, RNAV (GPS) RWY 14, Amdt 1
Staples, MN, Staples Muni, RNAV (GPS) RWY 32, Amdt 1
Hawthorne, NV, Hawthorne Industrial, RNAV (GPS) RWY 28, Orig
Hawthorne, NV, Hawthorne Industrial, Takeoff Minimums and Obstacle
DP, Orig
Las Vegas, NV, Mc Carran Intl, RNAV (GPS) RWY 1R, Amdt 2
Lovelock, NV, Derby Field, RNAV (GPS) RWY 2, Amdt 1
Lovelock, NV, Derby Field, RNAV (GPS) RWY 20, Orig
Lovelock, NV, Derby Field, VOR-A, Amdt 1
Caldwell, OH, Noble County, RNAV (GPS) RWY 23, Amdt 1
Baker City, OR, Baker City Muni, RNAV (GPS) RWY 13, Amdt 2
Columbia, SC, Columbia Metropolitan, ILS OR LOC RWY 5, Amdt 1D
Columbia, SC, Columbia Metropolitan, ILS OR LOC RWY 29, Amdt 3H
Columbia, SC, Columbia Metropolitan, RNAV (GPS) RWY 5, Amdt 2A
Columbia, SC, Columbia Metropolitan, RNAV (GPS) RWY 11, Amdt 1B
Columbia, SC, Columbia Metropolitan, RNAV (GPS) RWY 23, Amdt 2A
Columbia, SC, Columbia Metropolitan, RNAV (GPS) RWY 29, Amdt 1B
Watertown, SD, Watertown Rgnl, ILS OR LOC RWY 35, Amdt 11
Watertown, SD, Watertown Rgnl, LOC BC RWY 17, Amdt 11
Watertown, SD, Watertown Rgnl, RNAV (GPS) RWY 35, Amdt 1
Salt Lake City, UT, South Valley Rgnl, RNAV (GPS) RWY 34, Amdt 1
Salt Lake City, UT, South Valley Rgnl, RNAV (GPS) Z RWY 34, Orig-A,
CANCELED
Tooele, UT, Bolinder Field-Tooele Valley, ILS OR LOC RWY 17, Amdt 3
Tooele, UT, Bolinder Field-Tooele Valley, RNAV (GPS) RWY 17, Amdt 4
Seattle, WA, Boeing Field/King County Intl, RNAV (RNP) Z RWY 14R,
Amdt 1
Seattle, WA, Boeing Field/King County Intl, Takeoff Minimums and
Obstacle DP, Amdt 8

Effective 12 October 2017

Coldfoot, AK, Coldfoot, BETTLES TWO, Graphic DP
Coldfoot, AK, Coldfoot, RNAV (GPS) RWY 2, Amdt 2
Coldfoot, AK, Coldfoot, RNAV (GPS)-A, Amdt 1
Mekoryuk, AK, Mekoryuk, RNAV (GPS) RWY 23, Orig-A
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, ILS OR
LOC RWY 32, Amdt 3
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, ILS Z
RWY 32, Amdt 30B, CANCELED
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, RNAV
(GPS) RWY 1, Amdt 2
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, RNAV
(GPS) RWY 14, Amdt 1B
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, RNAV
(GPS) RWY 32, Amdt 2
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, Takeoff
Minimums and Obstacle DP, Amdt 8
Arcata/Eureka, CA, California Redwood Coast-Humboldt County, VOR RWY
14, Amdt 1C
San Andreas, CA, Calaveras Co-Maury Rasmussen Field, RNAV (GPS) RWY
31, Amdt 1
Cedar Rapids, IA, The Eastern Iowa, RNAV (GPS) RWY 27, Amdt 1A
Cedar Rapids, IA, The Eastern Iowa, RNAV (GPS) RWY 31, Amdt 1B
Iowa City, IA, Iowa City Muni, Takeoff Minimums and Obstacle DP,
Amdt 3B
Boise, ID, Boise Air Terminal/Gowen Fld, GOWEN THREE, Graphic DP
Nampa, ID, Nampa Muni, ADEXE ONE, Graphic DP
Nampa, ID, Nampa Muni, CADKI ONE, Graphic DP
Nampa, ID, Nampa Muni, NDB-A, Amdt 1A, CANCELED
Nampa, ID, Nampa Muni, RNAV (GPS) RWY 11, Amdt 2B
Nampa, ID, Nampa Muni, Takeoff Minimums and Obstacle DP, Amdt 3
Carrabassett, ME, Sugarloaf Rgnl, RNAV (GPS)-A, Orig
Carrabassett, ME, Sugarloaf Rgnl, Takeoff Minimums and Obstacle DP,
Orig
Jackson, MS, Jackson-Medgar Wiley Evers Intl, ILS OR LOC RWY 16L,
ILS RWY 16L (SA CAT I), ILS RWY 16L (CAT II), ILS RWY 16L (CAT III),
Amdt 8B
Jackson, MS, Jackson-Medgar Wiley Evers Intl, ILS OR LOC RWY 34L,
Amdt 6C
Jackson, MS, Jackson-Medgar Wiley Evers Intl, RNAV (GPS) RWY 16L,
Amdt 2B
Jackson, MS, Jackson-Medgar Wiley Evers Intl, RNAV (GPS) RWY 16R,
Amdt 2B
Jackson, MS, Jackson-Medgar Wiley Evers Intl, RNAV (GPS) RWY 34L,
Amdt 3B
Jackson, MS, Jackson-Medgar Wiley Evers Intl, RNAV (GPS) RWY 34R,
Amdt 2B
Lebanon, NH, Lebanon Muni, RNAV (GPS) RWY 7, Orig-E
Lebanon, NH, Lebanon Muni, RNAV (GPS) RWY 25, Orig-C
Lebanon, NH, Lebanon Muni, RNAV (GPS) RWY 36, Orig-C
Millville, NJ, Millville Muni, RNAV (GPS) RWY 14, Orig-E
Millville, NJ, Millville Muni, RNAV (GPS) RWY 28, Orig-B
Millville, NJ, Millville Muni, RNAV (GPS) RWY 32, Orig-C
Woodbine, NJ, Woodbine Muni, RNAV (GPS) RWY 19, Orig-B
Woodbine, NJ, Woodbine Muni, VOR-A, Amdt 1B
Jamestown, NY, Chautauqua County/Jamestown, ILS OR LOC RWY 25, Amdt
8
Oklahoma City, OK, Sundance, RNAV (GPS) RWY 18, Amdt 1D
Oklahoma City, OK, Sundance, RNAV (GPS) RWY 36, Amdt 1C
Oklahoma City, OK, Sundance, Takeoff Minimums and Obstacle DP, Amdt
2
Heber, UT, Heber City Muni--Russ McDonald Field, RNAV (GPS)-A, Amdt
3
Heber, UT, Heber City Muni--Russ McDonald Field, Takeoff Minimums
and Obstacle DP, Amdt 4
Seattle, WA, Seattle-Tacoma Intl, Takeoff Minimums and Obstacle DP,
Amdt 4A
Parkersburg, WV, Mid-Ohio Valley Rgnl, RNAV (GPS) RWY 3, Amdt 2B
Parkersburg, WV, Mid-Ohio Valley Rgnl, RNAV (GPS) RWY 21, Amdt 2C
Dixon, WY, Dixon, CARBON ONE, Graphic DP

Dixon, WY, Dixon, DIXON ONE, Graphic DP
Dixon, WY, Dixon, RNAV (GPS) RWY 24, Orig
Dixon, WY, Dixon, Takeoff Minimums and Obstacle DP, Orig
Greybull, WY, South Big Horn County, NDB RWY 34, Amdt 4
Greybull, WY, South Big Horn County, RNAV (GPS) RWY 8, Amdt 1
Greybull, WY, South Big Horn County, RNAV (GPS) RWY 34, Amdt 2
Greybull, WY, South Big Horn County, Takeoff Minimums and Obstacle
DP, Amdt 2

    Rescinded: On August 2, 2017 (82 FR 35896), the FAA published an
Amendment in Docket No. 31143, Amdt No. 3755 to Part 97 of the
Federal Aviation Regulations under section 97.20, 97.23, and 97.37.
The following entries for Arcata/Eureka, CA, Immokalee, FL, and Mc
Call, ID effective August 17, 2017, and are hereby rescinded in
their entirety:

Arcata/Eureka, CA, California Redwood Coast--Humboldt County,
Takeoff Minimums and Obstacle DP, Amdt 8
Immokalee, FL, Immokalee Rgnl, VOR RWY 18, Amdt 7
Mc Call, ID, Mc Call Muni, PEPUC TWO, Graphic DP

[FR Doc. 2017-19073 Filed 9-8-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Page 42561]
[FR Doc No: 2014-17185]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-003, OMB Control No. 3235-0009]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Regulation S-X

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information discussed below.
    Information collected and information prepared pursuant to
Regulation S-X focus on the form and content of, and requirements for,
financial statements filed with periodic reports and in connection with
the offer and sale of securities. Investors need reasonably current
financial statements to make informed investment and voting decisions.
    The potential respondents include all entities that file
registration statements or reports pursuant to the Securities Act of
1933 (15 U.S.C. 77a, et seq.), the Securities Exchange Act of 1934 (15
U.S.C. 78a, et seq.) or the Investment Company Act of 1940 (15 U.S.C.
80a-1, et seq.).
    Regulation S-X specifies the form and content of financial
statements when those financial statements are required to be filed by
other rules and forms under the federal securities laws. Compliance
burdens associated with the financial statements are assigned to the
rule or form that directly requires the financial statements to be
filed, not to Regulation S-X. Instead, an estimated burden of one hour
traditionally has been assigned to Regulation S-X for incidental
reading of the regulation. The estimated average burden hours are
solely for purposes of the Paperwork Reduction Act and are not derived
from a comprehensive or even a representative survey or study of the
costs of SEC rules or forms.
    Recordkeeping retention periods are based on the disclosure
required by various forms and rules other than Regulation S-X. In
general, balance sheets for the preceding two fiscal years, income and
cash flow statements for the preceding three fiscal years, and
condensed quarterly financial statements must be filed with the
Commission. Five year summary financial information is required to be
disclosed by some larger registrants.
    Filing financial statements, when required by the governing rule or
form, is mandatory. Because these statements are provided for the
purpose of disseminating information to the securities markets, they
are not kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the information discussed in this notice at
www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an email
to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F St. NE., Washington DC 20549 or send an email to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: July 16, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-17185 Filed 7-21-14; 8:45 am]
BILLING CODE 8011-01-P