82_FR_34995 82 FR 34852 - Electronic and Information Technology

82 FR 34852 - Electronic and Information Technology

DEPARTMENT OF STATE

Federal Register Volume 82, Issue 143 (July 27, 2017)

Page Range34852-34853
FR Document2017-15823

This rule provides a correction to a hyperlink included in the Section 508 implementing rule for the Department of State (the Department). The hyperlink takes the reader to a form that can be used by an employee or a member of the public to report accessibility issues to the Department, regarding its electronic and information technology.

Federal Register, Volume 82 Issue 143 (Thursday, July 27, 2017)
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34852-34853]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15823]


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DEPARTMENT OF STATE

22 CFR Part 147

[Public Notice: 10027]
RIN 1400-AE42


Electronic and Information Technology

AGENCY: Department of State.

ACTION: Final rule.

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

SUMMARY: This rule provides a correction to a hyperlink included in the 
Section 508 implementing rule for the Department of State (the 
Department). The hyperlink takes the reader to a form that can be used 
by an employee or a member of the public to report accessibility issues 
to the Department, regarding its electronic and information technology.

DATES: This rule is effective on August 28, 2017.

FOR FURTHER INFORMATION CONTACT: Alice Kottmyer, Attorney-Adviser, 202-
647-2318, [email protected].

SUPPLEMENTARY INFORMATION: Section 508 requires that when Federal 
departments and agencies develop, procure, maintain, or use electronic 
and information technology, they shall ensure that the electronic and 
information technology is accessible to individuals with disabilities. 
The Department's implementing regulations, in 22 CFR part 147, were 
published in 2016. Due to a re-configuration of Web site assets within 
the Department, the hyperlink included in Sec.  147.7(c) for the DS-
4282 (Discrimination Complaint Form), is no longer valid. This 
rulemaking corrects the link.
    The Department is preparing a more comprehensive update to Part 
147, which will align its rule with the final rule published by the 
Access Board (see 82 FR 5790); and to parts 142 and 144

[[Page 34853]]

(implementing Section 504 of the Rehabilitation Act), to update 
terminology consistent with modern practice. For those interested in 
tracking, the RIN for the Department's ``508 refresh'' is 1400-AE35; 
for Section 504, it is 1400-AE03.

Regulatory Analyses

    The Department of State is publishing this rulemaking as a final 
rule, pursuant to 5 U.S.C. 553(b). This rulemaking is a rule of agency 
organization, procedure, or practice. The effective date of the rule is 
30 days after publication, as provided in the Administrative Procedure 
Act.
    The Department further finds that this is not a major rule; is not 
subject to the Unfunded Mandates Reform Act of 1995; will not have 
tribal implications as defined by Executive Order 13175; and will not 
have an impact on a substantial number of small entities under the 
Regulatory Flexibility Act. This rule is not an economically 
significant rule under Executive Order 12866, and the Department 
certifies that the benefits of this rulemaking outweigh any costs, 
which are minimal for the public. The Office of Information and 
Regulatory Affairs has designated this rule as ``non-significant'', as 
defined by Executive Order 12866. As this rule is not a significant 
regulatory action, this rule is exempt from the requirements of 
Executive Order 13771, ``Reducing Regulation and Controlling Regulatory 
Costs.'' See OMB Memorandum M-17-21, ``Guidance Implementing Executive 
Order 13771'' of April 5, 2017.
    The Department of State has reviewed this rule in light of 
Executive Order 12988 to eliminate ambiguity, minimize litigation, 
establish clear legal standards, and reduce burden. This rule will not 
have substantial direct effect on the states, on the relationships 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government. 
Therefore, in accordance with Executive Order 13132, it is determined 
that this rule does not have sufficient federalism implications to 
require consultations or warrant the preparation of a federalism 
summary impact statement.
    The information collection referred to in this rulemaking has been 
approved by OMB. (OMB Control No. 1405-0220).

List of Subjects in 22 CFR Part 147

    Civil rights, Communications equipment, Computer technology, 
Government employees, Individuals with disabilities, Reporting and 
recordkeeping requirements, Telecommunications.

    For the reasons set forth in the preamble, 22 CFR part 147 is 
amended as follows:

PART 147--ELECTRONIC AND INFORMATION TECHNOLOGY

0
1. The authority citation for part 147 continues to read as follows:

    Authority:  22 U.S.C. 2651a; 29 U.S.C. 794, 794d; 36 CFR part 
1194.


Sec.  147.7   [Amended]

0
2. Amend Sec.  147.7 in paragraph (c) by removing ``https://eforms.state.gov/searchform.aspx '' and adding in its place ``https://eforms.state.gov/Forms/ds4282.PDF ''.

Janet Freer,
Director, Office of Directives Management, Department of State.
[FR Doc. 2017-15823 Filed 7-26-17; 8:45 am]
 BILLING CODE 4710-05-P



                                                34852                    Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations

                                                               TABLE 1—BALLOON AORTIC VALVULOPLASTY CATHETER RISKS AND MITIGATION MEASURES—Continued
                                                                                                             Identified risks                                                                                     Mitigation measures

                                                Inability for balloon deflation ................................................................................................................     Non-clinical performance evaluation.
                                                                                                                                                                                                     In Vivo evaluation.
                                                Increased balloon inflation and deflation times ...................................................................................                  Non-clinical performance evaluation.
                                                                                                                                                                                                     In Vivo evaluation.
                                                                                                                                                                                                     Labeling.
                                                Inability to steer towards valve of interest ...........................................................................................             Non-clinical performance evaluation.
                                                                                                                                                                                                     In Vivo evaluation.



                                                   FDA believes that special controls, in                               notification submissions, have been                                          Dated: July 21, 2017.
                                                combination with the general controls,                                  approved under OMB control number                                          Anna K. Abram,
                                                address these risks to health and                                       0910–0120, and the collections of                                          Deputy Commissioner for Policy, Planning,
                                                provide reasonable assurance of safety                                  information in 21 CFR part 801,                                            Legislation, and Analysis.
                                                and effectiveness.                                                      regarding labeling have been approved                                      [FR Doc. 2017–15786 Filed 7–26–17; 8:45 am]
                                                   Balloon aortic valvuloplasty catheters                               under OMB control number 0910–0485.                                        BILLING CODE 4164–01–P
                                                are not safe for use except under the
                                                                                                                        List of Subjects in 21 CFR Part 870
                                                supervision of a practitioner licensed by
                                                law to direct the use of the device. As                                   Medical devices.                                                         DEPARTMENT OF STATE
                                                such, the device is a prescription device                                 Therefore, under the Federal Food,
                                                and must satisfy prescription labeling                                  Drug, and Cosmetic Act and under                                           22 CFR Part 147
                                                requirements (see 21 CFR 801.109,                                       authority delegated to the Commissioner
                                                                                                                                                                                                   [Public Notice: 10027]
                                                Prescription devices).                                                  of Food and Drugs, 21 CFR part 870 is
                                                   Section 510(m) of the FD&C Act                                       amended as follows:                                                        RIN 1400–AE42
                                                provides that FDA may exempt a class
                                                II device from the premarket notification                               PART 870—CARDIOVASCULAR                                                    Electronic and Information Technology
                                                requirements under section 510(k), if                                   DEVICES
                                                                                                                                                                                                   AGENCY:    Department of State.
                                                FDA determines that premarket
                                                notification is not necessary to provide                                ■ 1. The authority citation for part 870                                   ACTION:   Final rule.
                                                reasonable assurance of the safety and                                  continues to read as follows:
                                                                                                                                                                                                   SUMMARY:    This rule provides a
                                                effectiveness of the device. For this type                                Authority: 21 U.S.C. 351, 360, 360c, 360e,                               correction to a hyperlink included in
                                                of device, FDA has determined that                                      360j, 360l, 371.                                                           the Section 508 implementing rule for
                                                premarket notification is necessary to                                  ■ 2. Add § 870.1255 to subpart B to read                                   the Department of State (the
                                                provide reasonable assurance of the                                     as follows:                                                                Department). The hyperlink takes the
                                                safety and effectiveness of the device.                                                                                                            reader to a form that can be used by an
                                                Therefore, this device type is not                                      § 870.1255         Balloon aortic valvuloplasty
                                                                                                                                                                                                   employee or a member of the public to
                                                exempt from premarket notification                                      catheter.
                                                                                                                                                                                                   report accessibility issues to the
                                                requirements. Persons who intend to                                        (a) Identification. A balloon aortic                                    Department, regarding its electronic and
                                                market this type of device must submit                                  valvuloplasty catheter is a catheter with                                  information technology.
                                                to FDA a premarket notification                                         a balloon at the distal end of the shaft,
                                                                                                                                                                                                   DATES: This rule is effective on August
                                                (510(k)), prior to marketing the device,                                which is intended to treat stenosis in
                                                                                                                                                                                                   28, 2017.
                                                which contains information about the                                    the aortic valve when the balloon is
                                                                                                                        expanded.                                                                  FOR FURTHER INFORMATION CONTACT:
                                                balloon aortic valvuloplasty catheter
                                                they intend to market.                                                     (b) Classification. Class II (special                                   Alice Kottmyer, Attorney-Adviser, 202–
                                                                                                                        controls). The special controls for this                                   647–2318, kottmyeram@state.gov.
                                                II. Analysis of Environmental Impact                                    device are:                                                                SUPPLEMENTARY INFORMATION: Section
                                                  We have determined under 21 CFR                                          (1) The device must be demonstrated                                     508 requires that when Federal
                                                25.34(b) that this action is of a type that                             to be biocompatible.                                                       departments and agencies develop,
                                                does not individually or cumulatively                                      (2) Sterility and shelf life testing must                               procure, maintain, or use electronic and
                                                have a significant effect on the human                                  demonstrate the sterility of patient-                                      information technology, they shall
                                                environment. Therefore, neither an                                      contacting components and the shelf life                                   ensure that the electronic and
                                                environmental assessment nor an                                         of these components.                                                       information technology is accessible to
                                                environmental impact statement is                                          (3) Non-clinical performance                                            individuals with disabilities. The
                                                required.                                                               evaluation must demonstrate that the                                       Department’s implementing regulations,
                                                                                                                        device performs as intended under                                          in 22 CFR part 147, were published in
                                                III. Paperwork Reduction Act of 1995                                    anticipated conditions of use, including                                   2016. Due to a re-configuration of Web
                                                  This final order establishes special                                  device delivery, inflation, deflation, and                                 site assets within the Department, the
                                                controls that refer to previously                                       removal.                                                                   hyperlink included in § 147.7(c) for the
                                                approved collections of information                                        (4) In vivo evaluation of the device                                    DS–4282 (Discrimination Complaint
mstockstill on DSK30JT082PROD with RULES




                                                found in other FDA regulations. These                                   must demonstrate device performance,                                       Form), is no longer valid. This
                                                collections of information are subject to                               including the ability of the device to                                     rulemaking corrects the link.
                                                review by the Office of Management and                                  treat aortic stenosis.                                                        The Department is preparing a more
                                                Budget (OMB) under the Paperwork                                           (5) Labeling must include a detailed                                    comprehensive update to Part 147,
                                                Reduction Act of 1995 (44 U.S.C. 3501–                                  summary of the device-related and                                          which will align its rule with the final
                                                3520). The collections of information in                                procedure-related complications                                            rule published by the Access Board (see
                                                part 807, subpart E, regarding premarket                                pertinent to the use of the device.                                        82 FR 5790); and to parts 142 and 144


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                                                                   Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations                                               34853

                                                (implementing Section 504 of the                           For the reasons set forth in the                    enforcement, call or email MST1
                                                Rehabilitation Act), to update                           preamble, 22 CFR part 147 is amended                  Jennifer Haggins, Marine Safety Unit
                                                terminology consistent with modern                       as follows:                                           Pittsburgh, U.S. Coast Guard; telephone
                                                practice. For those interested in                                                                              412–221–0807, email
                                                tracking, the RIN for the Department’s                   PART 147—ELECTRONIC AND                               Jennifer.L.Haggins@uscg.mil.
                                                ‘‘508 refresh’’ is 1400–AE35; for Section                INFORMATION TECHNOLOGY                                SUPPLEMENTARY INFORMATION: The Coast
                                                504, it is 1400–AE03.                                                                                          Guard will enforce special local
                                                                                                         ■ 1. The authority citation for part 147
                                                Regulatory Analyses                                                                                            regulations for the annual Three Rivers
                                                                                                         continues to read as follows:
                                                                                                                                                               Rowing Association/Head of the Ohio
                                                   The Department of State is publishing                   Authority: 22 U.S.C. 2651a; 29 U.S.C. 794,          Regatta in 33 CFR 100.801, Table 1
                                                this rulemaking as a final rule, pursuant                794d; 36 CFR part 1194.                               Sector Ohio Valley, No. 36 from 6 a.m.
                                                to 5 U.S.C. 553(b). This rulemaking is a                 § 147.7   [Amended]                                   until 3:30 p.m. each day from October
                                                rule of agency organization, procedure,                                                                        7, 2017 through October 8, 2017. Entry
                                                or practice. The effective date of the rule              ■ 2. Amend § 147.7 in paragraph (c) by                into the regulated area is prohibited
                                                is 30 days after publication, as provided                removing ‘‘https://eforms.state.gov/                  unless authorized by the Captain of the
                                                in the Administrative Procedure Act.                     searchform.aspx ’’ and adding in its                  Port Marine Safety Unit Pittsburgh
                                                   The Department further finds that this                place ‘‘https://eforms.state.gov/Forms/               (COTP) or a designated representative.
                                                is not a major rule; is not subject to the               ds4282.PDF ’’.                                        Persons or vessels desiring to enter into
                                                Unfunded Mandates Reform Act of                          Janet Freer,                                          or pass through the area must request
                                                1995; will not have tribal implications                  Director, Office of Directives Management,            permission from the COTP or a
                                                as defined by Executive Order 13175;                     Department of State.                                  designated representative. If permission
                                                and will not have an impact on a                         [FR Doc. 2017–15823 Filed 7–26–17; 8:45 am]
                                                                                                                                                               is granted, all persons and vessels shall
                                                substantial number of small entities                                                                           comply with the instructions of the
                                                                                                         BILLING CODE 4710–05–P
                                                under the Regulatory Flexibility Act.                                                                          COTP or designated representative.
                                                This rule is not an economically                                                                                  This notice of enforcement is issued
                                                significant rule under Executive Order                                                                         under authority of 33 CFR 100.801 and
                                                                                                         DEPARTMENT OF HOMELAND                                5 U.S.C. 552(a). In addition to this
                                                12866, and the Department certifies that                 SECURITY
                                                the benefits of this rulemaking outweigh                                                                       notice in the Federal Register, the Coast
                                                any costs, which are minimal for the                                                                           Guard will provide the maritime
                                                                                                         Coast Guard
                                                public. The Office of Information and                                                                          community with advance notification of
                                                Regulatory Affairs has designated this                                                                         this enforcement period via Local
                                                                                                         33 CFR Part 100
                                                rule as ‘‘non-significant’’, as defined by                                                                     Notice to Mariners and updates via
                                                Executive Order 12866. As this rule is                   [Docket No. USCG- 2017–0593]                          Marine Information Broadcasts.
                                                not a significant regulatory action, this                                                                        Dated: July 20, 2017.
                                                                                                         Special Local Regulations; Three
                                                rule is exempt from the requirements of                                                                        L. McClain, Jr.,
                                                                                                         Rivers Rowing Association/Head of the
                                                Executive Order 13771, ‘‘Reducing                                                                              Commander, U.S. Coast Guard, Captain of
                                                                                                         Ohio Regatta, Allegheny River Mile 0.0
                                                Regulation and Controlling Regulatory                                                                          the Port Marine Safety Unit Pittsburgh.
                                                                                                         to 4.0
                                                Costs.’’ See OMB Memorandum M–17–                                                                              [FR Doc. 2017–15829 Filed 7–26–17; 8:45 am]
                                                21, ‘‘Guidance Implementing Executive                    AGENCY:  Coast Guard, DHS                             BILLING CODE 9110–04–P
                                                Order 13771’’ of April 5, 2017.                          ACTION: Notice of enforcement of
                                                   The Department of State has reviewed                  regulation.
                                                this rule in light of Executive Order                                                                          DEPARTMENT OF HOMELAND
                                                12988 to eliminate ambiguity, minimize                   SUMMARY:   The Coast Guard will enforce               SECURITY
                                                litigation, establish clear legal                        a special local regulation during the
                                                standards, and reduce burden. This rule                  Three Rivers Rowing Association/Head                  Coast Guard
                                                will not have substantial direct effect on               of the Ohio Regatta on the Allegheny
                                                the states, on the relationships between                 River miles 0.0 to 4.0, for all navigable             33 CFR Part 117
                                                the national government and the states,                  waters of the river. This regulation is               [Docket No. USCG–2017–0697]
                                                or on the distribution of power and                      needed to protect vessels transiting the
                                                responsibilities among the various                       area and event spectators from the                    Drawbridge Operation Regulation;
                                                levels of government. Therefore, in                      hazards associated with the Three                     Columbia River, Portland, OR and
                                                accordance with Executive Order 13132,                   Rivers Rowing Association/Head of the                 Vancouver, WA
                                                it is determined that this rule does not                 Ohio Regatta. During the enforcement
                                                                                                         period, entry into, transiting, or                    AGENCY: Coast Guard, DHS.
                                                have sufficient federalism implications
                                                                                                         anchoring in the regulated area is                    ACTION:Notice of deviation from
                                                to require consultations or warrant the
                                                                                                         prohibited to all vessels not registered              drawbridge regulation.
                                                preparation of a federalism summary
                                                impact statement.                                        with the sponsor as participants or                   SUMMARY:   The Coast Guard has issued a
                                                   The information collection referred to                official patrol vessels, unless                       temporary deviation from the operating
                                                in this rulemaking has been approved                     specifically authorized by the Captain of             schedule that governs the Interstate 5 (I–
                                                by OMB. (OMB Control No. 1405–0220).                     the Port Marine Safety Unit Pittsburgh                5) Bridges across the Columbia River,
                                                                                                         (COTP) or a designated representative.                mile 106.5, between Portland, Oregon,
                                                List of Subjects in 22 CFR Part 147
mstockstill on DSK30JT082PROD with RULES




                                                                                                         DATES: The regulations in 33 CFR                      and Vancouver, Washington. The
                                                  Civil rights, Communications                           100.801, Table 1 Sector Ohio Valley, No.              deviation is necessary to facilitate the
                                                equipment, Computer technology,                          36 will be enforced from 6 a.m. until                 presence of participants in the Hands
                                                Government employees, Individuals                        3:30 p.m., each day from October 7,                   Across the Bridge Project. This
                                                with disabilities, Reporting and                         2017, through October 8, 2017.                        deviation allows the bridges to remain
                                                recordkeeping requirements,                              FOR FURTHER INFORMATION CONTACT: If                   in the closed-to-navigation position
                                                Telecommunications.                                      you have questions about this notice of               during the event.


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Document Created: 2017-07-27 02:07:23
Document Modified: 2017-07-27 02:07:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective on August 28, 2017.
ContactAlice Kottmyer, Attorney-Adviser, 202- 647-2318, [email protected]
FR Citation82 FR 34852 
RIN Number1400-AE42
CFR AssociatedCivil Rights; Communications Equipment; Computer Technology; Government Employees; Individuals with Disabilities; Reporting and Recordkeeping Requirements and Telecommunications

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