[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Page 18304]
[FR Doc No: 2020-06738]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88483; File No. SR-MIAX-2020-02]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Withdrawal of a Proposed Rule Change To Amend
MIAX Chapter XVII, Consolidated Audit Trail Compliance Rule

March 27, 2020.
    On January 24, 2020, Miami International Securities Exchange, LLC
(``MIAX Options'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend MIAX Options Chapter XVII, Consolidated
Audit Trail Compliance Rule. The proposed rule change was published for
comment in the Federal Register on February 5, 2020.\3\ On March 16,
2020, MIAX Options withdrew the proposed rule change (SR-MIAX-2020-02).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 88096 (January 30,
2020), 85 FR 6613.
    \4\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06738 Filed 3-31-20; 8:45 am]
 BILLING CODE 8011-01-P


United States Office of Science July, 2003 Environmental Protection and Technology Agency Washington, D. C.

Office of Water Addendum to Drinking Water Criteria Document for Monochloroacetic Acid and Trichloroacetic Acid Final Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD ii Draft, do not cite or quote Acknowledgements Chemical Manager/ Lead Scientist:

Diana Wong, Ph. D., DABT ( Office of Water)

Contractor Authors:

Bonnie Ransom Stern, M. P. H, Ph. D. ( GRAM, Inc., ICF Consulting Inc.,) Lynne Haber, Ph. D. ( TERA) Claudine Kasunic, M. S. ( GRAM, Inc.) Andrew Maier, C. I. H., Ph. D., ( TERA) Qiyu Zhao, Ph. D. ( TERA)

EPA Internal Reviewers:

Jon Reid, Ph. D. ( NCEA/ ORD) Steven Kueberuwa, Ph. D. ( OST/ OW) Joyce Morissey Donohue, Ph. D. ( OST/ OW)

External Peer Reviewers Patricia McGinnis, Ph. D. Ahmed Ahmed, Ph. D. Paul Brubaker, Ph. D. Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD iii Draft, do not cite or quote TABLE OF CONTENTS List of Figures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v List of Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi I. Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I 1 II. Physical and Chemical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II 1 III. Toxicokinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 1 A. Absorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 1 B. Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 6 C. Metabolism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 19 D. Excretion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 34 E. Bioaccumulation and Retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 44 F. PBPK Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 46 G. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 48 IV. Human Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 1 A. Drinking Water Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 1 A. 1 National Occurrence Data for MCA and TCA . . . . . . . . . . . . . . . . . . IV 1 A. 1.1 ICR Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 2 A. 1.2 Quarterly Distribution System Average and Highest Value for MCA and TCA . . . . . . . . . . . . . . . . . . . . . IV 3 A. 2 Factors Affecting the Relative Concentrations of MCA and TCA in Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 5 A. 2.1 Disinfection Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 5 A. 2.1.1 Disinfection Treatment in ICR Data Base . . . . . . . . . IV 9 A. 2.2 Bromide Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 12 A. 2.2.1 Bromide Concentration in the ICR Data Base . . . . IV 13 A. 2.3 Total Organic Carbon ( TOC) Concentration in the ICR Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 17 A. 2.4 Seasonal Shifts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 21 A. 2.4.1 Seasonal Shifts in ICR Database . . . . . . . . . . . . . . . IV 23 B. Exposure to Sources Other than Drinking Water . . . . . . . . . . . . . . . . . . . . IV 26 B. 1 Dietary Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 28 B. 2 Air Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 30 Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD iv Draft, do not cite or quote B. 3 Dermal Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 32 C. Overall Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 34 C. 1 Body Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 38 D. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 39 V. Health Effects in Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 1 A. Short Term Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 1 B. Long Term Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 13 C. Reproductive/ Developmental Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 24 D. Genotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 34 E. Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 40 F. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 55 VI. Health Effects in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 1 VII. Mechanisms of Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 1 A. Non cancer Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 1 B. Carcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 13 C. Sensitive Subpopulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 26 D. Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 31 E. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 34 VIII. Quantification of Toxicological Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 1 A. Introduction to Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 1 A. 1 Quantification of Noncarcinogenic Effects . . . . . . . . . . . . . . . . . . . VIII 1 A. 1.1 Reference Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 1 A. 1.2 Drinking Water Equivalent Level . . . . . . . . . . . . . . . . . . . . VIII 4 A. 1.3 Health Advisory Values . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 4 A. 2 Quantification of Carcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . VIII 6 B. Noncarcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 10 B. 1 Trichloroacetic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 11 Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD v Draft, do not cite or quote B. 1. a One Day Health Advisory for TCA . . . . . . . . . . . . . . . . . VIII 11 B. 1. b Ten Day Health Advisory for TCA . . . . . . . . . . . . . . . . . . VIII 11 B. 1. c Longer Term Health Advisory for TCA . . . . . . . . . . . . . . VIII 15 B. 1. d Reference Dose and Drinking Water Equivalent Level for TCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 21 B. 2 Monochloroacetic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 24 B. 2. a One Day Health Advisory for MCA . . . . . . . . . . . . . . . . . VIII 24 B. 2. b Ten Day Health Advisory for MCA . . . . . . . . . . . . . . . . . VIII 24 B. 2. c Longer Term Health Advisory for MCA . . . . . . . . . . . . . . VIII 26 B. 2. d Reference Dose and Drinking Water Equivalent Level for MCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 30 C. Carcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 33 C. 1 Trichloroacetic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 33 C. 2 Monochloroacetic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 35 D. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 36 IX. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX 1 Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD vi Draft, do not cite or quote List of Figures Figure II 1 Chemical Structures of the TCA and MCA . . . . . . . . . . . . . . . . . . . . . . . . . . . II 2 Figure III 1 Proposed Metabolism of TCA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 21 Figure III 2 Proposed Metabolism of MCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 30 Addendum to Drinking Water Criteria Document for Monochloroacetic and Trichloracetic Acid EPA/ OW/ OST/ HECD vii Draft, do not cite or quote List of Tables I 1 Summary of Health Advisory Values for Drinking Water. . . . . . . . . . . . . . . . . . . . . . I 21 II 1 Physical and Chemical Properties of TCA and MCA . . . . . . . . . . . . . . . . . . . . . . . . . II 1 III 1 Toxicokinetic Data for TCA in F344 Rats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 3 IV 1 MCA and TCA Quarterly Distribution System Average and Highest Value. . . . . . . . IV 4 IV 2 MCA by Disinfection Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 10 IV 3 TCA by Disinfection Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 11 IV 4 MCA by Influent Bromide Concentration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 15 IV 5 TCA by Influent Bromide Concentration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 16 IV 6 MCA by Influent Total Organic Carbon ( TOC) Concentration. . . . . . . . . . . . . . . . IV 18 IV 7 TCA by Influent Total Organic Carbon ( TOC) Concentration. . . . . . . . . . . . . . . . . IV 19 IV 8 MCA by Sample Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 24 IV 9 TCA by Sample Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 25 IV 10 MCA and TCA in Foods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 30 VIII 1 Summary of Oral Studies of TCA Toxicity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 36 VIII 2 Summary of Oral Studies of MCA Toxicity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 40 VIII 3 Summary of Development of the HA's and DWEL for TCA. . . . . . . . . . . . . . . . . VIII 44 VIII 4 Summary of Development of the HA's and DWEL for MCA. . . . . . . . . . . . . . . . VIII 45


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6220-6222]
[DOCID:fr08fe10-79]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0024]

Information Collection Requirements for the Variance Regulations;
Submission for Office of Management and Budget's (OMB) Approval of
Information Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits comments concerning its proposal to obtain OMB
approval for the information collection requirements contained in
Sections 6(b)6(A), 6(b)6(B), 6(b)6(C), 6(d), and 16 of the Occupational
Safety and Health Act of 1970, and 29 CFR 1905.10, 1905.11, and
1905.12. These statutory and regulatory provisions specify the
requirements for submitting applications to OSHA for temporary,
experimental, permanent, and national defense variances.

DATES: Comments must be submitted (postmarked, transmitted, or
received) by April 9, 2010.

ADDRESSES: Submit comments as follows:
     Electronically: Submit comments and attachments
electronically at

http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for submitting comments.
     Facsimile: OSHA allows facsimile transmission of comments,
including attachments, that are no longer than 10 pages in length. Send
these documents to the OSHA Docket Office at<PHONE_NUMBER>; OSHA does
not require hard copies of these documents. However, if commenters do
not transmit attachments (e.g., studies, journal articles), they must
submit one hard copy of the attachments to the OSHA Docket Office,
Technical Data Center, Room N-2625, OSHA, U.S. Department of Labor, 200
Constitution Ave., NW., Washington, DC 20910. These attachments must
clearly identify the sender's name, date, subject, and docket number
(i.e., OSHA-2009-0024) so that the Agency can attach them to the
appropriate comments.
     Regular mail, express mail, or messenger or courier
service: When using one of these methods, submit one hard copy of
comments and attachments (e.g., studies, journal articles) to the OSHA
Docket Office, Docket No. OSHA-2009-0024, Technical Data Center, Room
N-2625, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210 (telephone:<PHONE_NUMBER>) (TTY:<PHONE_NUMBER>).
Note that security-related procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, or
messenger or courier service. The hours of operation for the OSHA
Docket Office are 8:15 a.m.-4:45 p.m., e.t.
     Instructions: All submissions must include the Agency name
and the OSHA docket number for this Information Collection Request
(ICR) (OSHA Docket No. OSHA-2009-0024). OSHA places comments and other
material, including any personal information, in the public docket
without revision, and will make this information available online at
http://www.regulations.gov. For further information on submitting
comments, see section IV (``Public Participation'') of this notice.
     Docket: To read or download comments or other material in
the docket, including the companion supporting statement, go to http://
www.regulations.gov or the OSHA Docket Office at the address above.
However, some information (e.g., copyrighted material) is not publicly
available to read or download through this Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. Contact the OSHA Docket Office for
information about materials not available through the Web site, and for
assistance in using the Internet to locate docket submissions.

FOR FURTHER INFORMATION CONTACT: Todd Owen, Directorate of Standards
and Guidance, OSHA, Room N-3609, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the correct format, reporting burden (time and costs)
is minimal, collection instruments are clearly understandable, and
OSHA's estimate of the information collection burden is correct. The
Occupational Safety and Health Act of 1970 (OSH Act; 29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or developing information
regarding the causes and prevention of occupational injuries,
illnesses, and accidents (29 U.S.C. 657).
    Sections 6(b)6(A), 6(b)6(B), 6(b)6(C), 6(d), and 16 of the OSH Act,
and 29 CFR 1905.10, 1905.11, and 1905.12, specify the procedures that
employers must follow to apply for a variance from the requirements of
an OSHA standard. OSHA uses the information collected under these
procedures to: (1) Evaluate the employer's claim that the alternative
means of compliance would provide affected employees with the requisite
level of health and safety protection; (2) assess the technical
feasibility of the alternative means of compliance; (3) determine that
the employer properly notified affected employees of the variance
application and their right to a hearing; and (4) verify that the
application contains the administrative information required by the
applicable variance regulation. Currently, no specific forms are
available for preparing variance applications and other documents that
may accompany variance applications. OSHA is developing new forms to
assist employers in preparing variance applications that comply with
the information collection requirements contained in the OSH Act and
variance regulations.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected;
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques; and
     Whether providing variance application forms on the
Agency's Web site would reduce the burden on employers applying for
variances.

III. Proposed Actions

    OSHA is requesting OMB approval for the information collection
(paperwork) requirements contained in Sections 6(b)6(A), 6(b)6(B),
6(b)6(C), 6(d), and 16 of the Occupational Safety and Health Act of
1970, and 29 CFR 1905.10, 1905.11, and 1905.12. These statutory and
regulatory provisions specify the requirements for submitting
applications to OSHA for temporary, experimental, permanent, and
national defense variances.
    OSHA also is requesting OMB approval to develop and use variance
application forms for the four types of variances specified by the OSH
Act and variance regulations. The four types of variances are:
Temporary variances (Section 6(b)(6)(A) of the Act; 29 U.S.C. 655; 29
CFR 1905.10); experimental variances (Section 6(b)(6)(C) of the Act; 29
U.S.C. 655); permanent variances (Section 6(d) of the Act; 29 U.S.C.
655; 29 CFR 1905.11); and national defense variances (Section 16 of the
Act; 29 U.S.C. 665; 29 CFR 1905.12). The variance regulations specify
the information that employers must provide when requesting one of
these variances. The variance application forms would organize and
clarify the information collection requirements for each type of
variance by specifying the requirements in comprehensible language, and
providing explanatory material. Employers applying for a variance could
download and complete

the applicable form from OSHA's Web site. The forms would expedite the
application process for employers, and ensure that the information on
the application is complete and accurate.
    The Agency will summarize the comments submitted in response to
this notice, and will include this summary in its request to OMB to
approve these information collection requirements and variance
application forms.
    Type of Review: Existing collection in use without an OMB control
number.
    Title: Information Collection Requirements for the Variance
Regulations.
    OMB Number: 1218-0NEW.
    Affected Public: Business or other for-profit and not-for-profit
institutions.
    Number of Respondents: 12.
    Frequency of Recordkeeping: On occasion.
    Total Responses: 12.
    Average Time per Response: Ranges from 2 hours for an employer to
assemble the application documents to 16 hours to locate and assemble
information required to complete an application.
    Estimated Total Burden Hours: 366.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation: Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    Submit comments in response to this document: (1) Electronically at
http://www.regulations.gov, which is the Federal eRulemaking Portal;
(2) by facsimile (fax); or (3) by hard copy. All comments, attachments,
and other material must identify the Agency name and the OSHA docket
number for the ICR (OSHA Docket No. OSHA-2009-0024). To supplement
electronic submissions, upload document files electronically. Send hard
copies of materials to supplement electronic or facsimile submissions
to the OSHA Docket Office (see the ADDRESSES section of this notice).
The additional materials must clearly identify the associated
electronic comments by name, date, and docket number so OSHA can attach
them to the comments. Note that security-related procedures may result
in significant delays in receiving comments and other written materials
by regular mail. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for information about security procedures concerning
delivery of materials by express mail, or messenger or courier service.
The hours of operation for the OSHA Docket Office are 8:15 a.m.-4:45
p.m., e.t.
    OSHA posts comments and other submissions without revision at
http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as Social Security numbers and
birth dates. Some information (e.g., copyrighted material) is not
publicly available to read or download through http://
www.regulations.gov. However, all submissions, including copyrighted
material, are available for inspection and copying at the OSHA Docket
Office. Information on using the http://www.regulations.gov Web site to
submit comments and access the docket is available at the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the Web site, and for assistance
in using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007
(72 FR 31160).

    Signed at Washington, DC, on January 29, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-2659 Filed 2-5-10; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Rules and Regulations]
[Pages 49784-49786]
[FR Doc No: 2018-21378]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0142; Product Identifier 2018-NE-04-AD; Amendment
39-19368; AD 2018-17-14]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF34-8E
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
General Electric Company (GE) CF34-8E turbofan engines. This AD was
prompted by a report from GE regarding a quality escape of
nonconforming thrust reverser fire seals. This AD requires a one-time
inspection of the gap between the core cowl seal and the pylon seal of
the thrust reverser for correct gap width, and replacement of the
seals, if needed. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective November 7, 2018.

ADDRESSES: For service information identified in this final rule,
contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
telephone<PHONE_NUMBER>; email: [email protected]. You may
view this service information at the FAA, Engine and Propeller
Standards Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call 781-
238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0142.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0142; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC, 20590.

FOR FURTHER INFORMATION CONTACT: David Bethka, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7129; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain GE CF34-8E turbofan
engines. The NPRM published in the Federal Register on April 17, 2018
(83 FR 16794). The NPRM was prompted by a report from the manufacturer
about a fire seal gap quality escape on GE CF34-8E turbofan engines.
Some thrust reverser fire seals, installed on thrust reverser part
numbers (P/Ns) 15G0002-013, 15G0002-014, 15G0003-013, and 15G0003-014,
were shipped from a supplier with nonconforming seal gaps. The NPRM
proposed to require a one-time inspection of the gap between the core
cowl seal and the pylon seal of the thrust reverser for correct gap
width, and replacement of the thrust reverser fire seals, if needed. We
are issuing this AD to address the unsafe condition on these products.

Comments

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

Request To Change the Applicability

    Two commenters, Horizon Air and Republic Airline, requested that we
limit the applicability of this AD to a specific group of GE CF34-8E
turbofan engine thrust reverser halves that are known to have a fire
seal gap nonconformance. A change of applicability from all GE CF34-8E
turbofan engines to only the known group of affected thrust reverser
halves would reduce the inspection burden on operators.
    We agree. We changed the applicability of this AD to list only the
affected half thrust reverser P/Ns and serial numbers. We also updated
the number of affected thrust reverser assemblies and estimated costs.

Request To Change Required Actions

    Horizon Air requested that we change the required actions of this
AD to replace ``all GE CF34-8E turbofan engines'' with ``all thrust
reversers listed in paragraph (c).''
    We agree. We reworded the required actions of this AD to indicate
that these actions are only required for GE CF34-

8E turbofan engines with affected half thrust reversers installed.

Conclusion

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

Related Service Information

    We reviewed GE CF34-8E Service Bulletin (SB) 78-0066 R01, dated
June 20, 2018. The SB describes procedures for measuring the width of
the RTV filled gap between the thrust reverser fire seals at the 12
o'clock core cowl seal and pylon seal installed on thrust reverser P/Ns
15G0002-013, 15G0002-014, 15G0003-013, and 15G0003-014, and replacing
with parts eligible for installation, if needed.

Costs of Compliance

    We estimate that this AD affects 194 thrust reverser assemblies
installed on airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  0.25 work-hours x $85                 $0          $21.25       $4,122.50
                                         per hour = $21.25.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of aircraft that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Remove and replace thrust reverser fire      2.75 work-hours x $85 per hour =             $3,228       $3,461.75
 seals.                                       $233.75.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-17-14 General Electric Company: Amendment 39-19368 Docket No.
FAA-2018-0142; Product Identifier 2018-NE-04-AD.

(a) Effective Date

    This AD is effective November 7, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) CF34-8E
turbofan engines with:
    (1) Left-hand (LH) half thrust reverser, part number (P/N)
15G0002-013, or LH half thrust reverser P/N 15G0002-014, with the
following serial numbers (S/Ns): HRD00659 to HRD00662, HRD00675 to
HRD00678,

HRD00680, HRD00681, HRD00694 to HRD00697, HRD00711, HRD00831,
HRD00856, HRD00878 to HRD00895, HRD01025, HRD01040, HRD01047,
HRD01050 to HRD01057, HRD01059 to HRD01089, HRD01104, HRD01105,
HRD01108, HRD01111 to HRD01116, HRD01118 to HRD01121, HRD01123,
HRD01124, HRD01126, HRD01162, HRD01185 to HRD01198, HRD01201,
HRD01202, or HRD01226 to HRD01243, installed.
    (2) Right-hand (RH) half thrust reverser, P/N 15G0003-013, or RH
half thrust reverser P/N 15G0003-014, with the following S/Ns:
HRD00669 to HRD00678, HRD00680, HRD00681, HRD00703 to HRD00707,
HRD00722, HRD00825, HRD00919, HRD00922, HRD01018, HRD01022,
HRD01023, HRD01027 to HRD01033, HRD01035, HRD01036, HRD01038,
HRD01039, HRD01041 to HRD01046, HRD01048, HRD01049, HRD01059 to
HRD01079, HRD01081, HRD01082, HRD01084 to HRD01092, HRD01100,
HRD01117, HRD01140, HRD01146, HRD01162, HRD01185 to HRD01187,
HRD01189 to HRD01198, HRD01201, HRD01202, HRD01210, or HRD01213 to
HRD01223, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7830, Thrust
Reverser.

(e) Unsafe Condition

    This AD was prompted by a report from GE regarding a quality
escape of nonconforming thrust reverser fire seal gaps. We are
issuing this AD to inspect for nonconforming thrust reverser fire
seal gaps that could result in a fire outside the fire zone. The
unsafe condition, if not addressed, could result in an uncontrolled
fire, damage to the engine, and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) For all half thrust reversers listed in paragraph (c) of
this AD, before the half thrust reverser accumulates 8,000 flight
hours after the effective date of this AD, perform the following
one-time inspection, and, if needed, replace the core cowl seal and
pylon seal.
    (i) Measure the width of the RTV filled gap between thrust
reverser fire seals at the junction between 12 o'clock core cowl
seal and pylon seal, at the following half thrust reverser
locations: LH half thrust reverser, P/N 15G0002-013; LH half thrust
reverser, P/N 15G0002-014; RH half thrust reverser, P/N 15G0003-013;
and RH half thrust reverser P/N 15G0003-014.
    (ii) If the gap width between the 12 o'clock core cowl seal and
the pylon seal is greater than 1 mm, replace both seals with parts
eligible for installation to form a new gap of 1 mm or less, prior
to returning to service.
    (2) You may refer to GE CF34-8E Service Bulletin 78-0066 R01,
dated June 20, 2018, for guidance on inspecting and replacing the
thrust reverser fire seals.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (i) of this AD. You may email your request
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local Flight Standards District Office/Certificate Holding
District Office.

(i) Related Information

    For more information about this AD, contact David Bethka,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

(j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on September 26, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-21378 Filed 10-2-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Rules and Regulations]
[Pages 37005-37007]
[FR Doc No: 2011-15789]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0437]
RIN 1625-AA00

Safety Zone; Fan Pier Yacht Club Fireworks, Boston Harbor,
Boston, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone within
the Sector Boston Captain of the Port (COTP) Zone for the Fan Pier
Yacht Club Fireworks display. This safety zone is necessary to provide
for the safety of life on navigable waters during the fireworks event.
Entering into, transiting through, mooring or anchoring within this
zone is prohibited unless authorized by the COTP or the designated on-
scene representative.

DATES: This rule is effective and will be enforced from 9:30 p.m. to 10
p.m. on June 30, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0437 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0437 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail MST1 David Labadie of the Waterways
Management Division, U.S. Coast Guard Sector Boston; telephone 617-223-
3010, e-mail<EMAIL_ADDRESS>If you have questions on viewing
material related to the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because sufficient information regarding the
dates and scope of the event was not received in time to publish a NPRM
followed by a final rule as the event would occur before the rulemaking
process was complete. The Coast Guard was notified of this event on May
5, 2011. The sponsor was not aware of the requirements for submitting
an application for a marine event 135 days in advance, resulting in a
late notification to the Coast Guard. The sponsor is aware of this
requirement for all future events. The sponsor is unable to reschedule
this event due to other activities being held in conjunction with the
fireworks display. Due to the dangers posed by the pyrotechnics used in
this fireworks display, the safety zone is necessary to provide for the
safety of event participants, spectator craft, and other vessels
transiting the event area. For the safety concerns noted, it is in the
public interest to have these regulations in effect during the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this rule would expose spectators, vessels and other property to the
hazards associated with pyrotechnics used in the fireworks display.

Basis and Purpose

    The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295,
116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to define safety
zones.
    The safety zone is being issued to establish a temporary regulated
area in Boston Harbor around the fireworks launch barge during the
fireworks display.

Discussion of Rule

    This temporary rule is necessary to ensure the safety of
spectators, vessels and other property from the hazards associated with
fireworks display. The COTP Boston has determined that fireworks
displays in close proximity to watercraft and waterfront structures
pose a significant risk to public safety and property. Such hazards
include obstructions to the waterway that may cause marine casualties
and the explosive danger of fireworks and debris falling into the water
that may cause death or serious bodily harm. Establishing a safety zone
around the location of this fireworks event will help ensure the safety
of spectators, vessels and other property and help minimize the
associated risks.
    The Coast Guard has implemented safety zones for past events and
has not received public comments or concerns regarding the impact to
waterway traffic from these events.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    The Coast Guard determined that this rule is not a significant
regulatory action for the following reasons: The safety zone will be of
limited duration and is designed to avoid, to the extent

possible, fishing and recreational boating traffic routes. The
fireworks will also be coordinated to ensure there is no interruption
of commercial vessel transits.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
would not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to enter,
transit through, moor or anchor in portions of Boston Harbor during a
fireworks display.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will only be in effect for \1/2\ hour and vessels will be able to
transit around the safety zone. The fireworks will also be coordinated
around commercial vessels traffic to avoid interruption of transits.
Before the effective period, we will issue maritime advisories widely
available to users of the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. If the rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact MST1 David Labadie at the
telephone number or e-mail address indicated under the FOR FURTHER
INFORMATION CONTACT section of this notice.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human

environment. This rule is categorically excluded, under figure 2-1,
paragraph (34)(g), of the Instruction. This rule involves the
establishment of a safety zone. An environmental analysis checklist and
a categorical exclusion determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and
160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-437 to read as follows:

Sec.  165.T01-437  Safety Zone; Fan Pier Yacht Club Fireworks, Boston
Harbor, Boston, Massachusetts.

    (a) General. A temporary safety zone is established for the
fireworks display as follows:
    (1) Location. All waters of Boston Harbor, from surface to bottom,
within a 150-yard radius of position 42[deg]21.13' N; 071[deg]02.11' W.
This position is located in the Boston Harbor near the Boston Fish
Pier.
    (2) Enforcement Period. This rule is effective and will be enforced
from 9:30 p.m. to 10 p.m. on June 30, 2011.
    (b) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entering into, transiting through, mooring
or anchoring within this regulated area is prohibited unless authorized
by the Captain of the Port (COTP) Boston, or the designated on-scene
representative.
    (2) The ``on-scene representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
COTP Boston to act on his behalf. The on-scene representative will be
aboard either a Coast Guard or Coast Guard Auxiliary vessel.
    (3) Vessel operators desiring to enter or operate within the
regulated area shall contact the COTP or the designated on-scene
representative via VHF channel 16 or<PHONE_NUMBER> (Sector Boston
command center) to obtain permission to do so.
    (4) Vessel operators given permission to enter or operate in the
regulated area must comply with all directions given to them by the
Captain of the Port or the designated on-scene representative.

    Dated: June 10, 2011.
John N. Healey,
Captain, U.S. Coast Guard, Captain of the Port Boston.
[FR Doc. 2011-15789 Filed 6-23-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Notices]
[Page 68087]
[FR Doc No: 2016-23760]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; 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 13D and Regulation 13G; Schedule 13D and Schedule
13G, SEC File No. 270-137, OMB Control No. 3235-0145

    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'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the office of Management and
Budget for extension and approval.
    Schedules 13D and 13G are filed pursuant to Sections 13(d) and
13(g) of the Securities Exchange Act and Regulations 13D and 13G
thereunder to report beneficial ownership of equity securities
registered under Section 12 of the Exchange Act. Regulations 13D and
13G provide investors, the subject issuers, and market participants
with information about the accumulation of equity securities that may
have the potential to change or influence control of an issuer.
Schedules 13D and 13G are filed by persons, including small entities,
to report their ownership of more than 5% of a class of equity
securities registered under Section 12. We estimate that it takes
approximately 14.5 burden hours to prepare a Schedule 13D and that it
is filed by approximately 1,508 respondents. In addition, we estimate
that 25% of the 14.5 hours per response (3.625 hours per response) is
carried internally by the respondent for a total annual reporting
burden of 5,467 hours (3.625 hours per response x 1,508 responses).
    We estimate that it takes approximately 12.4 burden hours to
prepare Schedule 13G and that it is filed by approximately 7,079
respondents. We estimate that 25% of the 12.4 hours per response (3.1
hours per response) is carried internally by the respondent for a total
annual reporting burden of 21,945 hours (3.1 hours per response x 7,079
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    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.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549.

    Dated: September 27, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-23760 Filed 9-30-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 33009-33011]
[FR Doc No: 2015-14179]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-
2000-8398; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-2005-20027; FMCSA-
2005-20560; FMCSA-2006-25246; FMCSA-2007-27333]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
20 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective June 26, 2015. Comments must be
received on or before July 10, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-1998-
4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-2000-8398; FMCSA-2001-
9258; FMCSA-2003-14504; FMCSA-2005-20027; FMCSA-2005-20560; FMCSA-2006-
25246; FMCSA-2007-27333], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received

without change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

II. Exemption Decision

    This notice addresses 20 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 20 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Gary A. Barrett (IA)
Ivan L. Beal (NE)
Johnny A. Beutler (SD)
Brett L. Condon (MD)
Christopher A. Deadman (MI)
William K. Gullett (KY)
Daryl A. Jester (DE)
James P. Jones (ME)
Clyde H. Kitzan (ND)
Larry J. Lang (MI)
Spencer E. Leonard (OH)
William A. Moore, Jr. (NV)
Richard S. Rehbein (MN)
Bernard E. Roche (VA)
Luis H. Sanchez (WI)
David E. Sanders (NC)
David B. Speller (MN)
Lynn D. Veach (IA)
Harry S. Warren (FL)
Michael C. Wines (MD)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 20 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (63 FR 66226; 64 FR 16517; 65 FR 20245; 65 FR 45817; 65 FR
57230; 65 FR 77066; 65 FR 78256; 66 FR 16311; 66 FR 17743; 66 FR 17994;
66 FR 33990; 67 FR 57266; 68 FR 13360; 68 FR 19598; 68 FR 33570; 68 FR
35772; 70 FR 2701; 70 FR 16887; 70 FR 17504; 70 FR 25878; 70 FR 30997;
70 FR 33937; 72 FR 180; 72 FR 9397; 72 FR 12666; 72 FR 25831; 72 FR
28093; 72 FR 32705; 74 FR 6211; 74 FR 15586; 74 FR 26464; 76 FR 21796;
76 FR 34135; 78 FR 34140). Each of these 20 applicants has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the requirement specified at
49 CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

IV. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-2000-
8398; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-2005-20027; FMCSA-2005-
20560; FMCSA-25246; FMCSA-2007-27333), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, got to http://www.regulations.gov
and put the docket number, ``FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-
2000-7363; FMCSA-2000-8398; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-
2005-20027; FMCSA-2005-20560; FMCSA-25246; FMCSA-2007-27333'' in the
``Keyword'' box, and click ``Search.'' When the new

screen appears, click on ``Comment Now!'' button and type your comment
into the text box in the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the facility, please
enclose a stamped, self-addressed postcard or envelope. FMCSA will
consider all comments and material received during the comment period
and may change this notice based on your comments.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov and in the search box insert the docket number,
``FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-2000-8398;
FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-2005-20027; FMCSA-2005-20560;
FMCSA-25246; FMCSA-2007-27333'' in the ``Keyword'' box and click
``Search.'' Next, click ``Open Docket Folder'' button choose the
document listed to review. If you do not have access to the Internet,
you may view the docket online by visiting the Docket Management
Facility in Room W12-140 on the ground floor of the DOT West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., e.t., Monday through Friday, except Federal holidays.

    Issued on: May 21, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-14179 Filed 6-9-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56595-56597]
[FR Doc No: 2020-20166]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC20-25-000]

Commission Information Collection Activities (Ferc-717); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Energy.

ACTION: Notice of extension information collection and request for
comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (``Commission''
or ``FERC'') is soliciting public comment on the extension to the
information collection, FERC-717 (Standards for Business Practices and
Communication Protocols for Public Utilities) which will be submitted
to the Office of Management and Budget (OMB) for a review of the
information collection requirements.

DATES: Comments on the collection of information are due November 13,
2020.

ADDRESSES: Please submit a copy of your comments to the Commission
(identified by Docket No. IC20-25-000) by one of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
     U.S. Postal Service Mail: Persons unable to file
electronically may mail similar pleadings to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
     Effective 7/1/2020, delivery of filings other than by
eFiling or the U.S.

Postal Service should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER> (toll-free),
or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-717, Standards for Business Practices and Communication
Protocols for Public Utilities.
    OMB Control No.: 1902-0173.
    Type of Request: Three-year approval of the FERC-717 information
collection requirements with no changes to the current reporting
requirements.\1\
---------------------------------------------------------------------------

    \1\ This collection notice does not address the NOPR for RM05-29
and RM05-30.
---------------------------------------------------------------------------

    Abstract: The Commission directs all public utilities that own,
control or operate facilities for transmitting energy in interstate
commerce to provide certain types of information regarding their
transmission operations on an Open Access Same-time Information System
(OASIS). The Commission does not believe that open-access
nondiscriminatory transmission services can be completely realized
until it removes real-world obstacles that prevent transmission
customers from competing effectively with the Transmission Provider.
One of the obstacles is unequal access to transmission information. The
Commission believes that transmission customers must have simultaneous
access to the same information available to the Transmission Provider
if truly nondiscriminatory transmission services are to be a reality.
    The Commission also established Standards of Conduct requiring that
personnel engaged in transmission system operations function
independently from personnel engaged in marketing functions. The
Standards of Conduct were designed to prevent employees of a public
utility (or any of its affiliates) engaged in marketing functions from
preferential access to OASIS-related information or from engaging in
unduly discriminatory business practices. Companies were required to
separate their transmission operations/reliability functions from their
marketing/merchant functions and prevent system operators from
providing merchant employees and employees of affiliates with
transmission-related information not available to all customers at the
same time through public posting on the OASIS.
    Type of Respondents: Transmission Owners and Transmission
Operators.
    Estimate of Annual Burden \2\: The Commission estimates an
adjustment in the annual public reporting burden for the FERC-717. The
adjustment is due to Transmission Providers being allowed to file
responses jointly or individually. The Transmission Provider may
delegate this responsibility to a Responsible Party such as another
Transmission Provider, an Independent System Operator, a Regional
Transmission Group, or a Regional Reliability Council. The number
comprise two separate entities: Transmission Owners and Transmission
Operators. The responses submitted are our best estimate of the
Transmission Operators and remaining individual Transmission Owners.
The rationale is that some Transmission Owners have elected to turn
over operational control of their collective transmission systems to
Transmission Operators, including RTOs/ISOs (as authorized in 18 CFR
37.5). These Transmission Operators offer OASIS access to the
collective systems facilitating a single OASIS transmission request
serving multiple transmission systems. As a result of these efficiency
gains, the lower respondent count is appropriate.
---------------------------------------------------------------------------

    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 Code of Federal Regulations 1320.3.
---------------------------------------------------------------------------

    As a result of the efficiency gains, and an overestimate of the
respondents in our past requests, we are submitting a more accurate
number of respondents. The estimate below reflects the work associated
with the current information collection requirements:

         FERC-717, Standards for Business Practices and Communication Protocols for Public Utilities \3\
----------------------------------------------------------------------------------------------------------------
                                                                                Total annual
    Information collection        Number of     Annual number   Total number    Average burden    burden hours &
         requirements            respondents    of responses    of responses   hours & cost per    total annual
                                               per respondent                    response \4\          cost
                                          (1)             (2)     (1) * (2) =  (4).............  (3) * (4) = (5)
                                                                          (3)
----------------------------------------------------------------------------------------------------------------
FERC-717.....................             162               1             162  30 hrs.; $2,490.  4,860 hrs.;
                                                                                $403,380.
FERC-717 (compliance with                 165               1             165  10 hrs.; \6\      1,650 hrs.;
 standards, one-time) \5\.                                                      $830.             $136,950.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............             327  ................  6,510 hrs.;
                                                                                $540,330.
----------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use

of automated collection techniques or other forms of information
technology.
---------------------------------------------------------------------------

    \3\ This collection includes the one-time burden (over a 3 year
period of time) for the Final Rule RM05-25,05-26,05-27 [ICR
Reference No:<PHONE_NUMBER>-006]
    \4\ The Commission staff thinks that the average respondent for
this collection is similarly situated to the Commission, in terms of
salary plus benefits. Based upon FERC's FY 2020 annual average of
$172,329, (for salary plus benefits), the average hourly cost is
$83/hour.
    \5\ FERC-717 corresponds to OMB Control No. 1902-0173 that
identifies the information collection associated with Standards for
Business Practices and Communication Protocols for Public Utilities.
    \6\ The 30-hour estimate was developed in Docket No. RM05-5-013,
when the Commission prepared its estimate of the scope of work
involved in transitioning to the NAESB Version 002.1 Business
Practice Standards. See Order No. 676-E, 129 FERC 61,162 at P 134.
(FERC-717, 165 * 30 = 4,950 hrs./3 = 1,650 hrs./year)

    Dated: September 8, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-20166 Filed 9-11-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65667-65670]
[FR Doc No: 2013-25973]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0283]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Chemistry, Manufacturing, and Controls Postapproval Manufacturing
Changes To Be Documented in Annual Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 (the PRA).

DATES: Fax written comments on the collection of information by
December 2, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title. Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<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: ``Guidance for Industry on CMC Postapproval
Manufacturing Changes To Be Documented in Annual Reports.'' This
guidance provides recommendations to holders of new drug applications
(NDAs) and abbreviated new drug applications (ANDAs) regarding the
types of chemistry, manufacturing, and controls (CMC) postapproval
manufacturing changes that FDA has determined will likely have a
minimal potential to have an adverse effect on product quality (i.e.,
drug product identity, strength, quality, purity, or potency), and
therefore, should be documented by applicants in an annual report under
21 CFR 314.70(d).
    Description of Respondents: Respondents to this collection of
information are applicants of approved NDAs and ANDAs for finished drug
products and active pharmaceutical ingredients (APIs) intended for
human use.
    Burden Estimate: The number of CMC manufacturing supplements for
NDAs and ANDAs has continued to increase over the last several years.
In connection with FDA's Pharmaceutical Product Quality Initiative and
its risk-based approach to CMC review, FDA has evaluated the types of
changes that have been submitted in CMC postapproval manufacturing
supplements and determined that many of the changes being reported
present low risk to the quality of the product and do not need to be
submitted in supplements. Based on the risk-based evaluation, FDA
developed a list (attached as Appendix in the ``Guidance for Industry
on CMC Postapproval Manufacturing Changes To Be Documented in Annual
Reports'') to provide additional current recommendations to companies
regarding some postapproval manufacturing changes for NDAs and ANDAs
that may be considered to have a minimal potential to have an adverse
effect on product quality, and, therefore, may be classified as a
change to be documented in the next annual report (i.e., notification
of a change after implementation) rather than in a supplement.
    FDA is requesting OMB approval for the information collection
reduction resulting from the annual submissions, as required by
Sec. Sec.  314.70, 314.71, 314.81(b)(2), and 314.97 (21 CFR 314.70,
314.71, 314.81(b)(2), and 314.97), described in this document. Sections
314.70 and 314.71 require that supplements be submitted to FDA for
certain changes to an approved application. Section 314.81(b)(2)
requires that annual reports be submitted to FDA (Form FDA 2252).
Section 314.97 sets forth requirements for submitting supplements to an
approved ANDA for changes that require FDA approval. In addition, Sec.
314.98(c) requires annual reports and other post-marketing reports for
ANDAs. The estimate for annual reports for ANDAs is included under
Sec.  314.81(b)(2). Other postmarketing reports under Sec.  314.98 are
not affected by this notice.
    The guidance describes our current thinking on the interpretation
of these requirements. Part of the intent for the guidance is to reduce
the burden of reporting some manufacturing changes. Currently, for
postapproval changes considered to be major, applicants must submit and
receive FDA approval of a supplemental application to the NDA or ANDA
before the product made with the manufacturing change is distributed.
If a change is considered to be moderate, an applicant must submit a
supplement at least 30 days before the product is distributed or, in
some cases, submit a supplement at the time of distribution. If a
change is considered to be minor, an applicant may proceed with the
change, but must notify FDA of the change in the annual report. The
guidance describes the types of postapproval changes that applicants of
NDAs and ANDAs currently submit in supplements to NDAs or ANDAs but
that, under the guidance, may now be documented in annual reports. As a
result, applicants would no longer need to submit supplements for such
changes.
    FDA currently has OMB approval for the collection of information
entitled ``Application for Food and Drug Administration Approval to
Market a New Drug'' (OMB Control Number 0910-0001). This collection of
information includes the requirements imposed by the regulations under
21 CFR part 314 on applicants who apply for approval of an NDA or ANDA
to market or change an approved application. In particular, among other
things, this collection of information includes: (1) The submission of
supplements to FDA for certain changes to an approved application in
accordance with Sec. Sec.  314.70 and 314.71; (2) the submission of
annual reports to FDA (Form FDA 2252) in accordance with Sec.
314.81(b)(2); (3) the submission of supplements to an approved ANDA for
changes that require FDA approval; and (4) other postmarketing reports
for ANDAs in accordance with Sec.  314.98(c), of which the estimate for
annual reports is included under Sec.  314.81(b)(2). Therefore, this
information collection includes the supplements to NDAs and ANDAs and
the annual reports for NDAs and ANDAs that are described in the
guidance.
    Under the applicable regulations and the guidance, the following
changes would occur to the current approval by OMB under the PRA for
supplements to NDAs under Sec. Sec.  314.70 and 314.71 and supplements
to ANDAs under Sec.  314.97. Although the submission of supplements to
NDAs and ANDAs is approved under OMB Control Number 0910-0001, the
total number of supplements submitted per year is estimated to reduce
based on the recommendations in the guidance because certain changes
submitted as supplements would now be documented in annual reports.
Therefore, for such changes, the information collection with respect to
the submission of supplements will be reduced. Because the number of
supplements per year is estimated to reduce, the total number of hours
for preparing supplements would correspondingly reduce. In the Federal
Register of June 25, 2010 (75 FR 36421), FDA published the notice of
availability for the draft guidance, including the information
collection analysis required under the PRA. We received the following
comments that pertained to the collection of information resulting from
the guidance.

    Comments on Issue One: Several comments noted that, in addition to
FDA regulations on postapproval changes at Sec. Sec.  314.70 and
314.71, FDA has issued multiple guidances that provide recommendations
on how the Agency wishes to be notified of postapproval changes. These
guidances include the ``Guidance for Industry on Changes to an Approved
NDA or ANDA,'' the ``Guidance for Industry on Changes to an Approved
NDA or ANDA--Questions and Answers,'' the ``Guidance for Industry on
Scale-Up and PostApproval Changes (SUPAC),'' the ``Guidance for
Industry on Bulk Active Chemicals--Postapproval Changes II (BACPAC),''
the ``Draft Guidance for Industry on CMC Postapproval Manufacturing
Changes Reportable in Annual Reports'' (the guidance that is the
subject of this Federal Register notice), and others.
    The comments said that this adds duplication, complexity,
redundancy, and the potential for confusion to the postapproval CMC
regulatory environment. For example, the comments noted that while some
of the changes described in the ``Draft Guidance for Industry on CMC
Postapproval Manufacturing Changes Reportable in Annual Reports'' are
already included in the existing ``Guidance for Industry on Changes to
an Approved NDA or ANDA,'' other changes to be documented in annual
reports such as a move to a different manufacturing site for secondary
packaging and labeling described in the ``Guidance for Industry on
Changes to an Approved NDA or ANDA'' are not contained in the ``Draft
Guidance for Industry on CMC Postapproval Manufacturing Changes
Reportable in Annual Reports.''
    The comments recommended that all CMC changes to be documented in
annual reports be consolidated into a single, updated guidance document
to help ensure consistency, avoid confusion, and simplify the process
for assessing change. The comments also recommended that the ``Draft
Guidance for Industry on CMC Postapproval Manufacturing Changes
Reportable in Annual Reports'' be withdrawn and that its
recommendations be incorporated into an updated version of the
``Guidance for Industry on Changes to an Approved NDA or ANDA.''
    FDA Response on Issue One: The ``Final Guidance for Industry on CMC
Postapproval Manufacturing Changes To Be Documented in Annual Reports''
now includes Appendices A and B, which provides examples of chemistry,
manufacturing, and control-related postapproval changes to be
documented in annual reports. Section V. ``Resources'' of the guidance
lists other previously published CMC guidances in which CMC changes to
be documented in annual reports also are mentioned, along with changes
that are required to be documented according to Sec.  314.70(b) and
(c).
    Comments on Issue Two: Several comments said that some of the
examples given in the draft guidance for changes previously submitted
under manufacturing supplements that should now be documented in an
annual report (because the Agency has determined those change to be of
generally low risk to product quality) are problematic because some of
these changes are current good manufacturing practice changes (CGMPs)
and would not have previously been reported at all but kept on file for
FDA inspection. The comments said that changes that do not have an
adverse effect on product quality data can be made available to FDA on
request or during an inspection and do not need to be documented in the
annual report. The comment said that the recommendations of the draft
guidance to document these changes in the annual report will increase,
not reduce, industry's regulatory reporting burden.
    In addition, the comments noted that the draft guidance's
recommendation that CMC changes to be documented in annual reports be
supported by, among other things, a reference to affected validation
protocols, standard operating procedures, and policies also would
increase industry's regulatory reporting burden because these documents
are frequently updated and revised, and FDA's CGMP regulations require
this information to be kept on file and presented to FDA on request or
during an inspection.
    FDA Response on Issue Two: The guidance clarifies that executed
batch records, standard operating procedures (SOPs), and data from
studies and tests performed to assess the effects of each change listed
in Appendix A should be kept on file and made available to the Agency
on request (e.g., during an inspection). Section IV. ``Contents of
Annual Report Notification'' of the guidance has been revised from the
draft guidance to address many of industry's comments stated in the
previous paragraph. Summary of data, cross references to change control
and change validation protocols, and SOPs that were used to assess or
demonstrate the effect of the change are recommended for inclusion in
the annual report. These are expected to allow the Agency to
efficiently determine whether the appropriate reporting category has
been used.
    Comments on Issue Three: One comment said that many of the
recommendations found in Appendix A, Sections 1-3 of the draft guidance
(Components and Composition, Manufacturing Sites, and Manufacturing
Process) reference information that FDA regulations do not require. The
comment said that this may result in an overly conservative approach to
annual reports and the submission of a large amount of unnecessary
information. As an example, the comment said that Appendix A, Section
1.2 (lines 147-149) of the draft guidance states that the following can
be documented in an annual report: ``New supplier of inactive
ingredients that have a minimal effect on product performance in the
drug product, providing that acceptance criteria remain unchanged.''
The comment noted that if the inactive ingredient meets compendial
standards, the supplier need not be specified in the original
application, and if the supplier of that inactive ingredient is later
changed, that information does not need to be submitted to FDA if the
inactive ingredient also is a compendial standard. As another example,
the comment said that Appendix A, Section 2.2 (lines 161-162) of the
draft guidance states that: ``Addition of barriers to prevent routine
in-process human intervention in a filling or compounding area that is
qualified and validated by established procedures.'' The comment said
that this is not routinely required to be documented in an annual
report.
    FDA Response on Issue Three: In response to the comments received
on the draft guidance, the Agency has clarified the applicable
circumstance when information on the new supplier(s) of inactive
ingredient should be documented in the annual report. It is clarified
that documenting the ``addition of barriers within a conventional fill
area'' in an annual report would apply to the manufacturing of sterile
products.
    The estimates described in this document are based on FDA's data of
the number of supplements and annual reports submitted annually to NDAs
and ANDAs, as well as the Agency's familiarity with the time needed to
prepare supplements and annual reports. The total number of supplements
submitted per year is estimated to reduce based on the recommendations
in the guidance. Based on the number of CMC manufacturing supplements
received for NDAs and ANDAs, FDA estimates that it will receive
annually approximately 800 responses under Sec. Sec.  314.70 and

314.71 for NDAs and approximately 2,075 responses under Sec.  314.97
for ANDAs. The number of annual frequencies per response is estimated
to decrease. FDA estimates that approximately the same number of
respondents will submit responses under Sec. Sec.  314.70, 314.71, and
314.97 and each response will take approximately the same amount of
time to prepare as in the information collection currently approved
under OMB Control Number 0910-0001.
    As set forth in the following table, the estimated annual reporting
burden for this information collection is 286,000 hours. In the future,
it is estimated that the Agency would reduce the currently approved
burden (OMB Control Number 0910-0001) for Sec. Sec.  314.70 and 314.71
for NDAs and Sec.  314.97 for ANDAs by reducing the number of
supplements for those postapproval CMC changes that can be documented
in annual reports as recommended in the ``Guidance for Industry on CMC
Postapproval Manufacturing Changes To Be Documented in Annual
Reports.''
    FDA estimates the burden on this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Annual
                Activity                      Number of respondents        frequency per   Total annual         Hours per response          Total hours
                                                                             response        responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements and Annual Reports for NDAs  281 (same as currently                     2.85             800  150 (same as currently                 120,000
                                          approved).                                                       approved).
Supplements and Annual Reports for       215 (same as currently                     9.65           2,075  80 (same as currently                  166,000
 ANDAs.                                   approved).                                                       approved).
                                        ----------------------------------------------------------------------------------------------------------------
    Total Hours........................                                                                                286,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25973 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P