Food Safety and Inspection Service
Economic Analysis Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Navy Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Geological Survey
Land Management Bureau
National Park Service
Federal Bureau of Investigation
United States Marshals Service
Federal Aviation Administration
Federal Railroad Administration
Maritime Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Board of Governors of the Federal Reserve System.
Final rule.
The Board of Governors of the Federal Reserve System (the Board) is issuing its final rule to revise and expand its equal employment opportunity regulation to adopt recent changes the Equal Employment Opportunity Commission (EEOC) made to its rules. The Board's rule is intended to provide Board employees, applicants for employment, and others with the same substantive and procedural rights generally guaranteed to others under Title VII of the Civil Rights Act of 1964, the Equal Pay Act, the Age Discrimination in Employment Act, and the Rehabilitation Act and thus to comply with the spirit of those laws. The Board's rule also clarifies provisions related to Board employees' right to bring a claim before the Merit System Protection Board and the Federal Labor Relations Board.
Effective date: July 11, 2019.
Sheila Clark, Program Director, Office of Diversity and Inclusion, Board of Governors of the Federal Reserve System, (202) 452-2883.
The terms of Board employment are established by the Federal Reserve Act and rules established by the Board. 12 U.S.C. 244 (providing that the “employment, compensation, leave, and expenses” of Board employees “shall be governed solely by the provisions of this chapter and rules and regulations of the Board not inconsistent therewith.”). Although the Board has broad discretion to establish the terms of Board employment and can establish terms that deviate from the rights afforded to other government employees, the Board, as a matter of policy, has long aligned its employment practices with Federal laws that provide for equal employment opportunity. Pursuant to this policy, part 268 was issued by the Board to provide equal opportunity in employment in compliance with the spirit of Title VII of the Civil Rights Act of 1964 (Title VII), the Equal Pay Act, the Age Discrimination in Employment Act, and the Rehabilitation Act.
On November 15, 2018, the Board issued a notice of proposed rulemaking with opportunity for public comment (NPR) in which it proposed amending part 268 in order to better align Board practices with those of the Equal Employment Opportunity Commission's (EEOC's) rules (83 FR 57343). The comment period for the proposed rule has now closed and a total of six public comments were received.
None of the commenters suggested substantive revisions to the proposed rule. Four commenters expressed general support for the proposed rule. One commenter did not express support or opposition to the proposal, but rather, commented on the difficulty of forming a bank and finding payment processors for the bank.
The final commenter opposed the proposed rule because the commenter believes the rule would further “affirmative action” which the commenter opposes. The commenter did not specifically state which portions of the proposal the commenter opposed nor did the commenter suggest specific changes to the rule. However, the comment was interpreted as opposing the portion of the proposed rule which commits the Board to the goal of ensuring that twelve percent of its employees are individuals with disabilities and two percent of its employees are individuals with targeted disabilities. Because the provisions regarding disabled employees reflect the EEOC's approach to employing disabled employees at other Federal agencies, the Board has decided to include these provisions in its final rule to ensure greater consistency between the Board's Equal Employment Opportunity (EEO) practices and those of other Federal agencies.
The Board has considered all comments received. Because the majority of the commenters supported the proposed rule and because the changes are necessary to conform the Board's EEO Regulation more closely to EEOC rules and to clarify Board employees' rights to bring claims before the Merit System Protection Board and the Federal Labor Relations Board, the Board has adopted amendments to its Rules Regarding Equal Opportunity as proposed without substantive change.
As noted in the NPR, the revisions to part 268 are described below:
1. Amend § 268.101 to prohibit discrimination on the basis of genetic information to ensure compliance with the Genetic Information Nondiscrimination Act of 2008 (GINA) and to make conforming changes throughout to reflect this change.
2. Amend § 268.102(b)(3) to clarify that the Board follows EEOC guidance and management directives relating to advice for ensuring compliance with Title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
3. Amend § 268.1 to remove references to hiring and granting information access since those rules will be incorporated into internal Board policies;
4. Amend § 268.106(a)(5) to adopt the EEOC's rule requiring dismissal of complaints that allege discrimination on the basis of proposed personnel actions or other preliminary steps unless the complainant has alleged that the proposal or preliminary step is retaliatory;
5. Amend § 268.107(e) to require Board staff, EEO investigators, and complainants to comply with the Board's program for the security of Federal Open Market Committee (FOMC) information when investigating and processing complaints that require access to FOMC information;
6. Amend § 268.107(g) to adopt the EEOC's rule on investigating complaints which requires agencies that have not completed an investigation within EEOC's time limits to send a notice to the complainant indicating the investigation is not complete, providing the date by which it will be completed, and explaining that the complainant has the right to request a hearing or file a lawsuit;
7. Amend § 268.201 to reflect updated address information for the EEOC;
8. Amend § 268.203 to more closely reflect the EEOC's approach to designing an affirmative action plan for individuals with disabilities;
9. Amend §§ 268.204 and 268.401 to reflect the EEOC's rules for processing class complaints;
10. Remove § 268.205 since its subject is not related to equal employment opportunity
11. Remove § 268.302 to eliminate procedures for handling mixed case complaints since mixed case complaints cannot be brought against the Board;
12. Amend § 268.403 to update address information and to incorporate the EEOC's rule that agencies submit appellate records and complaint files to the EEOC in a digital format that is acceptable to the EEOC;
13. Add a new § 268.405(b) to adopt the EEOC's procedures for class complaints which provide that an administrative judge's decision on the merits of a class complaint is a final decision which the Board can fully implement or appeal in its final action and to provide for expedited processing of appeals of decisions to accept or dismiss class complaints;
14. Amend § 268.502(c) to adopt the EEOC's rule which permits agencies up to 120 days to provide the particular relief the EEOC ordered; and
15. Amend § 268.710 to make changes to headings and titles to conform to the EEOC's rules and to the Board's functional titles.
Except as described below, the above changes are necessary to align the Board's employment practices and complaint processing with the EEOC's rules. The revisions to part 268 align the Board's practices with changes the EEOC has made to its rules on Federal Sector Equal Employment Opportunity found at 29 CFR part 1614. In addition, the amendment to § 268.102(b)(3) clarifies that the Board follows Commission guidance and management directives relating to advice for ensuring compliance with Title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
Currently part 268 requires Board staff, EEO investigators, and complainants to protect confidential information of the Board but does not expressly address confidential FOMC information. Because it is conceivable that a complainant could require access to FOMC information, and because FOMC information is not solely Board information, the Board is amending § 268.107(e)(2) to expressly require those seeking access to FOMC information to agree to abide by the Program for Security of FOMC Information before being granted access to such information. This will ensure that FOMC information is protected in the same manner as other confidential Board information.
The revisions also eliminate § 268.205, which discusses the Board's rules for hiring non-citizens and for allowing access to confidential supervisory information (CSI) and FOMC information. The subject matter of this section is not relevant to the Board's equal employment opportunity rules. Thus, the revisions remove this section from the Board's equal employment opportunity regulation. Going forward, rules relating to the hiring of non-citizens and governing access to CSI and FOMC information will be incorporated in the Board's internal management policies.
The revisions eliminate § 268.302, which addressed procedures that apply to “mixed case complaints.” A mixed case complaint is an employment complaint which raises violations of both EEO laws (over which the EEOC retains jurisdiction) and merit system principles, created by certain civil service laws over which the Merit Systems Protection Board (MSPB) retains jurisdiction. The Board is not subject to the MSPB's jurisdiction in light of its employment authorities under the Federal Reserve Act. Thus, the revisions remove this provision of the regulation.
The revisions to subpart H reflect changes to the Board's organizational structure since the last time the Board updated its EEO Regulation. Subpart H prohibits discrimination on the basis of disability in programs or activities conducted by the Board and describes how to file complaints alleging such discrimination. The complaint process described in subpart H incorporates references to position titles that are no longer in use at the Board. For example, subpart H refers to the Equal Employment Opportunity Office, which has since been replaced by the Office of Diversity and Inclusion; to an EEO Program Director, which has since been replaced by the Office of Diversity and Inclusion Program Director; and to a Staff Director for Management, which has been replaced by the Chief Operating Officer. The amendments to subpart H replace the out-of-date titles with up-to-date information each place the rule refers to such titles.
Certain provisions of the rule contain “collection of information” requirements within the meaning of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521). In accordance with the requirements of the PRA, the Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Board will address the information collection requirements associated with this rule under a separate
The Regulatory Flexibility Act, 5 U.S.C. 601
Section 722 of the Gramm-Leach-Bliley Act requires each Federal banking agency to use plain language in all rules published after January 1, 2000. In light of this requirement, the Board believes this rule is presented in a simple and straightforward manner and is consistent with this “plain language” directive.
Administrative practice and procedure, Aged, Civil rights, Equal employment opportunity, Federal buildings and facilities, Genetic information, Government employees, Individuals with disabilities, Religious discrimination, Sex discrimination, Wages.
For the reasons set forth in the preamble, the Board is amending 12 CFR part 268 as set forth below:
12 U.S.C. 244 and 248(i), (k) and (l).
(b)
(a) It is the policy of the Board to provide equal opportunity in employment for all persons, to prohibit discrimination in employment because of race, color, religion, sex, national origin, age, disability, or genetic information and to promote the full realization of equal opportunity in employment through a continuing affirmative program.
(b) No person shall be subject to retaliation for opposing any practice made unlawful by Title VII of the Civil Rights Act (title VII) (42 U.S.C. 2000e
The revisions read as follows:
(a) * * *
(4) Communicate the Board's equal employment opportunity policy and program and its employment needs to all sources of job candidates without regard to race, color, religion, sex, national origin, age disability, or genetic information, and solicit their recruitment assistance on a continuing basis;
(b) * * *
(3) Appraise its personnel operations at regular intervals to assure their conformity with the Board's program, this part and the instructions contained in the Commission's management directives relating to advice for ensuring compliance with the provisions of title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
(4) Designate a Director for Equal Employment Opportunity (EEO Programs Director), EEO Officer(s), and such Special Emphasis Program Managers/Coordinators (
(a) Individual and class complaints of employment discrimination and retaliation prohibited by title VII (discrimination on the basis of race, color, religion, sex and national origin), the ADEA (discrimination on the basis of age when the aggrieved person is at least 40 years of age), the Rehabilitation Act (discrimination on the basis of disability), the Equal Pay Act (sex-based wage discrimination), or GINA (discrimination on the basis of genetic information) shall be processed in accordance with this part. Complaints alleging retaliation prohibited by the statutes listed in this paragraph (a) are considered to be complaints of discrimination for purposes of this part.
(a) Aggrieved persons who believe they have been discriminated against on the basis of race, color, religion, sex, national origin, age, disability, or genetic information must consult a Counselor prior to filing a complaint in order to try to informally resolve the matter.
(d) Unless the aggrieved person agrees to a longer counseling period under paragraph (e) of this section, or the aggrieved person chooses an alternative dispute resolution procedure in accordance with paragraph (b)(2) of this section, the Counselor shall conduct the final interview with the aggrieved person within 30 days of the date the aggrieved person contacted the Board's Office of Diversity and Inclusion to request counseling. If the matter has not been resolved, the aggrieved person shall be informed in writing by the Counselor, not later than the thirtieth day after contacting the Counselor, of the right to file a discrimination complaint with the Board. This notice shall inform the complainant of the right to file a discrimination complaint within 15 days of receipt of the notice, of the appropriate official with whom to file a complaint and of the complainant's duty to assure that the Programs Director is informed immediately if the complainant retains counsel or a representative.
(a) * * *
(5) That is moot or alleges that a proposal to take a personnel action, or other preliminary step to taking a personnel action, is discriminatory, unless the complaint alleges that the proposal or preliminary step is retaliatory;
The additions read as follows.
(e) * * *
(2) * * * Confidential supervisory information, as defined in 12 CFR 261.2(c), and other confidential information of the Board may be included in the investigative file by the investigator, the EEO Programs Director, or another appropriate officer of the Board, where such information is relevant to the complaint. Neither the complainant nor the complainant's personal representative may make further disclosure of such information, however, except in compliance with the Board's Rules Regarding Availability of Information, 12 CFR part 261, and
(g) If the Board does not send the notice required in paragraph (f) of this section within the applicable time limits, it shall, within those same time limits, issue a written notice to the complainant informing the complainant that it has been unable to complete its investigation within the time limits required by paragraph (f) and estimating a date by which the investigation will be completed. Further, the notice must explain that if the complainant does not want to wait until the agency completes the investigation, he or she may request a hearing in accordance with paragraph (h) of this section, or file a civil action in an appropriate United States District Court in accordance with § 268.406(b). Such notice shall contain information about the hearing procedures.
(g)
(a) As an alternative to filing a complaint under this part, an aggrieved individual may file a civil action in a United States district court under the ADEA against the agency after giving the Commission not less than 30 days' notice of the intent to file such an action. Such notice must be filed in writing with EEOC, at P.O. Box 77960, Washington, DC 20013, or by personal delivery or facsimile within 180 days of the occurrence of the alleged unlawful practice.
(c) When an individual has filed an administrative complaint alleging age discrimination, administrative remedies will be considered to be exhausted for purposes of filing a civil action:
(a)
(1) The term
(2) The term
(3) The term
(4) The term
(5) The term
(6) The term
(7) [Reserved]
(8) The term
(9) The term
(10) The term
(b)
(c)
(d)
(1)
(A) Use of programs and resources that identify job applicants with disabilities, including individuals with targeted disabilities, who are eligible to be appointed under a hiring authority that takes disability into account, examples of which could include programs that provide the qualifications necessary for particular positions within the Board to individuals with disabilities, databases of individuals with disabilities who previously applied to the Board but were not hired for the positions they applied for, and training and internship programs that lead directly to employment for individuals with disabilities; and
(B) Establishment and maintenance of contacts (which may include formal
(ii)
(A) Ensuring that disability-related questions from members of the public regarding the agency's application and selection processes are answered promptly and correctly, including questions about reasonable accommodations needed by job applicants during the application and selection processes and questions about how individuals may apply for appointment under hiring authorities that take disability into account;
(B) Processing requests for reasonable accommodations needed by job applicants during the application and placement processes, and ensuring that the Board provides such accommodations when required to do so under the standards set forth in 29 CFR part 1630;
(C) Accepting applications for appointment under hiring authorities that take disability into account, if permitted under written Board policy;
(D) If an individual has applied for appointment to a particular position under a hiring authority that takes disability into account, determining whether the individual is eligible for appointment under such authority, and, if so, forwarding the individual's application to the relevant hiring officials with an explanation of how and when the individual may be appointed, consistent with all applicable laws; and
(E) Overseeing any other Board programs designed to increase hiring of individuals with disabilities.
(iii)
(A) Efforts to ensure that employees with disabilities are informed of and have opportunities to enroll in relevant training, including management training when eligible;
(B) Development or maintenance of a mentoring program for employees with disabilities; and
(C) Administration of exit interviews that include questions on how the Board could improve the recruitment, hiring, inclusion, and advancement of individuals with disabilities.
(2)
(3)
(A) Explain relevant terms such as “reasonable accommodation,” “disability,” “interactive process,” “qualified,” and “undue hardship,” consistent with applicable statutory and regulatory definitions, using examples where appropriate;
(B) Explain that reassignment to a vacant position for which an employee is qualified, and not just permission to compete for such position, is a reasonable accommodation, and that the Board must consider providing reassignment to a vacant position as a reasonable accommodation when it determines that no other reasonable accommodation will permit an employee with a disability to perform the essential functions of his or her current position;
(C) Notify supervisors and other relevant Board employees how and where they are to conduct searches for available vacancies when considering reassignment as a reasonable accommodation;
(D) Explain that an individual may request a reasonable accommodation orally or in writing at any time, need not fill out any specific form in order for the interactive process to begin, and need not have a particular accommodation in mind before making a request, and that the request may be made to a supervisor or manager in the individual's chain of command, the office designated by the Board to oversee the reasonable accommodation process, any Board employee connected with the application process, or any other individual designated by the Board to accept such requests;
(E) Include any forms the Board uses in connection with a reasonable accommodation request as attachments, and indicate that such forms are available in alternative formats that are accessible to people with disabilities;
(F) Describe the Board's process for determining whether to provide a reasonable accommodation, including the interactive process, and provide contact information for the individual or program office from whom requesters will receive a final decision;
(G) Provide guidance to supervisors on how to recognize requests for reasonable accommodation;
(H) Require that decision makers communicate, early in the interactive process and periodically throughout the process, with individuals who have requested a reasonable accommodation;
(I) Explain when the Board may require an individual who requests a reasonable accommodation to provide medical information that is sufficient to explain the nature of the individual's disability, his or her need for reasonable accommodation, and how the requested accommodation, if any, will assist the individual to apply for a job, perform the essential functions of a job, or enjoy the benefits and privileges of the workplace;
(J) Explain the Board's right to request relevant supplemental medical information if the information submitted by the requester is insufficient for the purposes specified in paragraph (d)(3)(i)(I) of this section;
(K) Explain the Board's right to have medical information reviewed by a medical expert of the Board's choosing at the Board's expense;
(L) Explain the Board's obligation to keep medical information confidential, in accordance with applicable laws and regulations, and the limited circumstances under which such information may be disclosed;
(M) Designate the maximum amount of time the Board has, absent extenuating circumstances, to either provide a requested accommodation or deny the request, and explain that the time limit begins to run when the accommodation is first requested;
(N) Explain that the Board will not be expected to adhere to its usual timelines if an individual's health professional fails to provide needed documentation in a timely manner;
(O) Explain that, where a particular reasonable accommodation can be provided in less than the maximum amount of time permitted under paragraph (d)(3)(i)(M) of this section, failure to provide the accommodation in a prompt manner may result in a violation of the Rehabilitation Act;
(P) Provide for expedited processing of requests for reasonable accommodations that are needed sooner than the maximum allowable time frame permitted under paragraph (d)(3)(i)(M) of this section;
(Q) Explain that, when all the facts and circumstances known to the Board make it reasonably likely that an individual will be entitled to a reasonable accommodation, but the accommodation cannot be provided immediately, the Board shall provide an interim accommodation that allows the individual to perform some or all of the essential functions of his or her job, if it is possible to do so without imposing undue hardship on the Board;
(R) Inform applicants and employees how they may track the processing of requests for reasonable accommodation;
(S) Explain that, where there is a delay in either processing a request for or providing a reasonable accommodation, the Board must notify the individual of the reason for the delay, including any extenuating circumstances that justify the delay;
(T) Explain that individuals who have been denied reasonable accommodations have the right to file complaints pursuant to 12 CFR 268.105;
(U) Encourage the use of voluntary informal dispute resolution processes that individuals may use to obtain prompt reconsideration of denied requests for reasonable accommodation;
(V) Provide that the Board shall give the requester a notice consistent with the requirements of paragraph (d)(3)(iii) of this section at the time a request for reasonable accommodation is denied; and
(W) Provide information on how to access additional information regarding reasonable accommodation, including, at a minimum, Commission guidance and technical assistance documents.
(ii)
(A) Ensure that anyone who is authorized to grant or deny requests for reasonable accommodation or to make hiring decisions is aware that, pursuant to the regulations implementing the undue hardship defense at 29 CFR part 1630, all resources available to the agency as a whole, excluding those designated by statute for a specific purpose that does not include reasonable accommodation, are considered when determining whether a denial of reasonable accommodation based on cost is lawful; and
(B) Ensure that anyone authorized to grant or deny requests for reasonable accommodation or to make hiring decisions is aware of, and knows how to arrange for the use of, Board resources available to provide the accommodation, including any centralized fund the Board may have for that purpose.
(iii)
(A) Explains the reasons for the denial and notifies the job applicant or employee of any available internal appeal or informal dispute resolution processes;
(B) Informs the job applicant or employee of the right to challenge the denial by filing a complaint of discrimination under this part;
(C) Provides instructions on how to file such a complaint; and
(D) Explains that, pursuant to 12 CFR 268.105, the right to file a complaint will be lost unless the job applicant or employee initiates contact with an EEO Counselor within 45 days of the denial, regardless of whether the applicant or employee participates in an informal dispute resolution process.
(4)
(A) Explains their rights under Section 508 of the Rehabilitation Act of 1973, 29 U.S.C. 794d, concerning the accessibility of agency technology, and the Architectural Barriers Act, 42 U.S.C. 4151 through 4157, concerning the accessibility of agency building and facilities;
(B) Provides contact information for a Board employee who is responsible for ensuring the physical accessibility of the Board's facilities under the Architectural Barriers Act of 1968, and a Board employee who is responsible for ensuring that the electronic and information technology purchased, maintained, or used by the agency is readily accessible to, and usable by, individuals with disabilities, as required by Section 508 of the Rehabilitation Act of 1973; and
(C) Provides instructions on how to file complaints alleging violations of the accessibility requirements of the Architectural Barriers Act of 1968 and Section 508 of the Rehabilitation Act of 1973.
(ii)
(5)
(A) The employee requires such services because of a targeted disability;
(B) Provision of such services would, together with any reasonable accommodations required under the standards set forth in 29 CFR part 1630, enable the employee to perform the essential functions of his or her position; and
(C) Provision of such services would not impose undue hardship on the Board.
(ii)
(iii)
(iv)
(v)
(6)
(ii)
(A) The individual's self-identification as an individual with a disability or an individual with a targeted disability on a form, including but not limited to the Office of Personnel Management's Standard Form 256, which states that the information collected will be kept confidential and used only for statistical purposes, and that completion of the form is voluntary;
(B) Records relating to the individual's appointment under a hiring authority that takes disability into account, if applicable; and
(C) Records relating to the individual's requests for reasonable accommodation, if any.
(iii)
(7)
(A) No less than 12% of employees who have salaries equal to or greater than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with disabilities;
(B) No less than 12% of employees who have salaries less than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with disabilities;
(C) No less than 2% of employees who have salaries equal to or greater than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with targeted disabilities; and
(D) No less than 2% of employees who have salaries less than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with targeted disabilities.
(ii)
(A) Increased use of hiring authorities that take disability into account to hire or promote individuals with disabilities or targeted disabilities, as applicable;
(B) To the extent permitted by applicable laws, consideration of disability or targeted disability status as a positive factor in hiring, promotion, or assignment decisions;
(C) Disability-related training and education campaigns for all employees in the Board;
(D) Additional outreach or recruitment efforts;
(E) Increased efforts to hire and retain individuals who require supported employment because of a disability, who have retained the services of a job coach at their own expense or at the expense of a third party, and who may be given permission to use the job coach during work hours as a reasonable accommodation without imposing undue hardship on the Board; and
(F) Adoption of training, mentoring, or internship programs for individuals with disabilities.
(8)
(i) The number of job applications received from individuals with disabilities, and the number of individuals with disabilities who were hired by the Board;
(ii) The number of job applications received from individuals with targeted disabilities, and the number of individuals with targeted disabilities who were hired by the Board;
(iii) All rescissions of conditional job offers, demotions, and terminations taken against applicants or employees as a result of medical examinations or inquiries;
(iv) All Board employees hired under special hiring authority for person with certain disabilities, and each such employee's date of hire, entering grade level, probationary status, and current grade level;
(v) The number of employees appointed under special hiring authority for persons with certain disabilities who successfully completed the Board's Provisional Employment period and the number of such employees who were terminate prior to the end of their Provisional Employment period; and
(vi) Details about each request for reasonable accommodation including, at a minimum—
(A) The specific reasonable accommodation requested, if any;
(B) The job sought by the requesting applicant or held by the requesting employee;
(C) Whether the accommodation was needed to apply for a job, perform the essential functions of a job, or enjoy the benefits and privileges of employment;
(D) Whether the request was granted (which may include an accommodation different from the one requested) or denied;
(E) The identity of the deciding official;
(F) If denied, the basis for such denial; and
(G) The number of days taken to process the request.
(e)
(i) A copy of its current Plan;
(ii) The results of the two most recent workforce analyses performed pursuant to paragraph (d)(6) of this section showing the percentage of employees with disabilities and employees with targeted disabilities in each of the designated pay groups;
(iii) The number of individuals appointed to positions within the Board under special hiring authority for persons with certain disabilities during the previous year, and the total number of employees whose employment at the Board began by appointment under special hiring authority for persons with certain disabilities; and
(iv) A list of changes made to the Plan since the prior submission, if any, and an explanation of why those changes were made.
(2)
(i)
(j)
(2) If the Board does not issue a final order within 60 days of receipt of the administrative judge's decision, then the decision of the administrative judge shall become the final action of the Board.
(3) A final order on a class complaint shall, subject to subpart E of this part, be binding on all members of the class and the Board.
(k)
(l) * * *
(3) * * * The claim must include a specific detailed showing that the claimant is a class member who was affected by the discriminatory policy or practice, and that this discriminatory action took place within the period of time for which class-wide discrimination was found in the final order. * * *
(c) A class agent or the Board may appeal an administrative judge's decision accepting or dismissing all or part of a class complaint; a class agent may appeal the Board's final action or the Board may appeal an administrative judge's decision on a class complaint; a class member may appeal a final decision on a claim for individual relief under a class complaint; and a class member, a class agent or the Board may appeal a final decision on a petition pursuant to § 268.204(g)(4).
(a) The complainant, the Board, agent or individual class claimant (hereinafter appellant) must file an appeal with the Director, Office of Federal Operations, Equal Employment Opportunity Commission, at P.O. Box 77960, Washington, DC 20013, or electronically, or by personal delivery or facsimile. The appellant should use EEOC Form 573, Notice of Appeal/Petition, and should indicate what is being appealed.
(g) The Board will submit appeals, complaint files, and other filings to the Commission's Office of Federal Operations in a digital format acceptable to the Commission, absent a showing of good cause why the Board cannot submit digital records. Appellants are encouraged, but not required, to submit digital appeals and supporting documentation to the Commission's Office of Federal Operations in a format acceptable to the Commission.
(a) The Office of Federal Operations, on behalf of the Commission, shall issue a written decision setting forth its reasons for the decision. The Commission shall dismiss appeals in accordance with §§ 268.106, 268.403(c) and 268.408. The decision shall be based on the preponderance of the evidence. The decision on an appeal from the Board's final action shall be based on a de novo review, except that the review of the factual findings in a decision by an administrative judge issued pursuant to § 268.108(i) shall be based on a substantial evidence standard of review. If the decision contains a finding of discrimination, appropriate remedy(ies) shall be included and, where appropriate, the entitlement to interest, attorney's fees or costs shall be indicated. The decision shall reflect the date of its issuance, inform the complainant of his or her civil action rights, and be transmitted to the complainant and the Board by first class mail.
(b) The Office of Federal Operations, on behalf of the Commission, shall issue decisions on appeals of decisions to accept or dismiss a class complaint issued pursuant to § 268.204(d)(7) within 90 days of receipt of the appeal.
(c) A decision issued under paragraph (a) of this section is final within the meaning of § 268.406 unless the Board issues a final decision under paragraph (d) of this section or unless a timely request for reconsideration is filed by a party to the case. A party may request reconsideration within 30 days of receipt of a decision of the Commission, which the Commission in its discretion may grant, if the party demonstrates that:
(1) The appellate decision involved a clearly erroneous interpretation of material fact or law; or
(2) The decision will have a substantial impact on the policies, practices, or operations of the Board.
(d) The Board, within 30 days of receiving a decision of the Commission, may issue a final decision based upon that decision, which shall be final within the meaning of § 268.406.
(b) * * *
(2) When the Board requests reconsideration, it may delay the payment of any amounts ordered to be paid to the complainant until after the request for reconsideration is resolved. If the Board delays payment of any amount pending the outcome of the request to reconsider and the resolution of the request (including under § 268.405(d)) requires the Board to make the payment, then the Board shall pay interest from the date of the original appellate decision until payment is made.
(c) When no request for reconsideration or final decision under § 268.405(d) is filed or when a request for reconsideration is denied, the Board shall provide the relief ordered and there is no further right to delay implementation of the ordered relief. The relief shall be provided in full not later than 120 days after receipt of the final decision unless otherwise ordered in the decision.
(c) Prior to rendering its determination, the Commission may request that the parties submit whatever additional information or documentation it deems necessary or may direct that an investigation or hearing on the matter be conducted. If the Commission determines that the Board is not in compliance with a decision or a settlement agreement, and the noncompliance is not attributable to acts or conduct of the complainant, it may order such compliance with the decision or settlement agreement, or, alternatively, for a settlement agreement, it may order that the complaint be reinstated for further processing from the point processing ceased. Allegations that subsequent acts of discrimination violate a settlement agreement shall be processed as separate complaints under § 268.105 or § 268.204, as appropriate, rather than under this section.
The revisions read as follows:
(c)
(d) * * *
(4)
Delaware River Basin Commission.
Final rule.
On July 1 of every year beginning July 1, 2017, the Commission's regulatory program fees are subject to an annual adjustment. This document provides notice of the Commission's regulatory program fees and schedule of water charges for the fiscal year beginning July 1, 2019.
This final rule is effective July 1, 2019.
Elba L. Deck, CPA, Director of Administration and Finance, 609-883-9500, ext. 201.
The Delaware River Basin Commission (“DRBC” or “Commission”) is a Federal-interstate compact agency charged with managing the water resources of the Delaware River Basin on a regional basis without regard to political boundaries. Its members are the governors of the four basin states—Delaware, New Jersey, New York and Pennsylvania—and on behalf of the federal government, the North Atlantic Division Commander of the U.S. Army Corps of Engineers.
In accordance with 18 CFR 401.43(c), on July 1 of every year beginning July 1, 2017, the Commission's regulatory program fees as set forth in Tables 1, 2 and 3 of that section are subject to an annual adjustment, commensurate with any increase in the annual April 12-month Consumer Price Index (CPI) for Philadelphia published by the U.S. Bureau of Labor Statistics during that year. Pursuant to 18 CFR 420.43(c), the same indexed adjustment applies to the Commission's schedule of water charges for consumptive and non-consumptive withdrawals of surface water within the basin. The referenced April 12-month CPI for 2019 showed an increase of 1.86%. Commensurate adjustments are thus required.
This document is made in accordance with 18 CFR 401.42(c) and 18 CFR 420.42(c), which provide that a revised fee schedule will be published in the
Administrative practice and procedure, Project review, Water pollution control, Water resources.
Water supply.
For the reasons set forth in the preamble, the Delaware River Basin Commission amends parts 401 and 420 of title 18 of the Code of Federal Regulations as set forth below:
Delaware River Basin Compact (75 Stat. 688), unless otherwise noted.
Delaware River Basin Compact, 75 Stat. 688.
(a) $84 per million gallons for consumptive use, subject to paragraph (c) of this section; and
(b) $0.84 per million gallons for non-consumptive use, subject to paragraph (c) of this section.
Coast Guard, DHS.
Notification of expired temporary rules issued.
This document provides notification of substantive rules issued by the Coast Guard that were temporarily effective primarily between March 2015 and June 2015 but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective primarily between March 2015 and June 2015, unless otherwise indicated, and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this document contact Deborah Thomas, Office of Regulations and Administrative Law, telephone (202) 372-3864.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between March 2015 and June 2015 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce certain safety zones located in the federal regulations for Annual Events in the Captain of the Port Buffalo. This action is necessary and intended to protect the safety of life and property on navigable waters prior to, during, and immediately after these events. During each enforcement period, no person or vessel may enter the respective safety zone without the permission of the Captain of the Port Buffalo.
The regulations in 33 CFR 165.939 as listed in Table 165.939 will be enforced for the events and times as stated in the
If you have questions about this notice of enforcement, call or email LT Sean Dolan, Chief of Waterways Management, U.S. Coast Guard Sector Buffalo telephone 716-843-9322, email
The Coast Guard will enforce the Safety Zones; Annual Events in the Captain of the Port Buffalo Zone listed in 33 CFR 165.939 for the following events:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within the safety zones during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or a designated representative. Those seeking permission to enter the safety zones may request permission from the Captain of Port Buffalo via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zones shall obey the directions of the Captain of the Port Buffalo or a designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.
This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing approval of revisions to the Utah Administrative Code (UAC), specifically R307-101-3 submitted by the State of Utah on October 13, 2016. This submittal requests a State Implementation Plan (SIP) revision to change the date of the referenced Code of
This rule is effective on July 11, 2019.
The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2018-0735. All documents in the docket are listed on the
Amrita Singh, Air and Radiation Division, EPA, Region 8, Mailcode 8ARD-QP, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6103,
Throughout this document “we,” “us,” and “our” means the EPA.
On April 9, 2019 (84 FR 14073), the EPA proposed to approve the SIP revision to R307-101-3, General Requirements; Version of Code of Federal Regulations Incorporated by Reference, where the version of the 40 CFR is being changed from July 1, 2014, to July 1, 2015. The submittal was signed by the Governor on August 17, 2016, and officially submitted by the State on October 13, 2016.
Additionally, within the October 13, 2016 submittal, the Utah Division of Air Quality (UDAQ) submitted revisions to R307-210, Stationary Sources, Standards of Performance for New Stationary Sources and R307-214, National Emissions Standards for Hazardous Air Pollutants. On April 9, 2019 (84 FR 14073), the EPA did not propose any action on these revisions since these rules have already been automatically delegated to the State of Utah.
The EPA did not receive any comments on the proposed action.
The EPA is finalizing approval of the SIP revision to R307-101-3, General Requirements; Version of Code of Federal Regulations Incorporated by Reference, where the date was changed from 2014 to 2015, signed by the Governor on August 17, 2016, and officially submitted by the State on October 13, 2016. Additionally, the EPA is finalizing its position to take no action on the revisions made to R307-210, Stationary Sources, Standards of Performance for New Stationary Sources and R307-214, National Emissions Standards for Hazardous Air Pollutants; since these rules have already been automatically delegated to the State of Utah.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of R307-101-3 into the SIP submitted by the State of Utah as discussed in the proposed rule. The EPA has made, and will continue to make, these materials generally available through
Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 12, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Greenhouse gases, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440); Model CL-600-2C10 (Regional Jet Series 700, 701 & 702); Model CL-600-2D15 (Regional Jet Series 705); Model CL-600-2D24 (Regional Jet Series 900); and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by reports of incorrect deployment of forward and aft flight attendant oxygen masks. This proposed AD would require repacking the flight attendant and lavatory oxygen box assemblies as applicable, replacing the placards, and re-identifying the assemblies. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by July 26, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
You may examine the AD docket on the internet at
Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-03, dated January 19, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Model CL-600-2B19 (Regional Jet Series 100 & 440); Model CL-600-2C10 (Regional Jet Series 700, 701 & 702); Model CL-600-2D15 (Regional Jet Series 705); Model CL-600-2D24 (Regional Jet Series 900); and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:
After an in-service cabin oxygen masks deployment on a CL-600-2D24 aeroplane, the crew noted that the forward and aft flight attendant oxygen masks did not deploy correctly. The oxygen hoses were tangled with the pull lanyard and cordage from the oxygen box assemblies. Investigation found the same condition on other aeroplanes. The similarly designed lavatory oxygen box assembly is also affected. It was determined that packing instructions for these oxygen box assemblies were incorrect. If not corrected, inappropriately packed oxygen box assemblies resulting in incorrectly deployed oxygen masks can cause occupant distress and delayed access to oxygen supply during a high altitude emergency.
This [Canadian] AD mandates the repacking of the forward flight attendant, aft flight attendant, and lavatory oxygen box assemblies [as applicable] and the installation of a revised packaging placard.
You may examine the MCAI in the AD docket on the internet at
Bombardier has issued the following service information:
• Service Bulletin 601R-35-021, dated October 30, 2017, which describes procedures for repacking the lavatory oxygen box assembly, replacing the placards, and re-identifying the assembly.
• Service Bulletin 670BA-35-015, dated October 30, 2017, which describes procedures for repacking the flight attendant and lavatory oxygen box assemblies, replacing the placards, and re-identifying the assemblies.
These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
We estimate that this proposed AD affects 539 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
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 proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by July 26, 2019.
None.
This AD applies to Bombardier, Inc., airplanes, certificated in any category, identified in paragraphs (c)(1) through (c)(4) of this AD.
(1) Model CL-600-2B19 (Regional Jet Series 100 & 440), serial numbers (S/N) 7003 and subsequent.
(2) Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), S/N 10003 and subsequent.
(3) Model CL-600-2D15 (Regional Jet Series 705) and Model CL-600-2D24 (Regional Jet Series 900), S/N 15001 and subsequent.
(4) Model CL-600-2E25 (Regional Jet Series 1000), S/N 19001 and subsequent.
Air Transport Association (ATA) of America Code 35, Oxygen.
This AD was prompted by reports of incorrect deployment of the forward and aft flight attendant oxygen masks. We are issuing this AD to address incorrect packing of the flight attendant and lavatory oxygen box assemblies, which could result in incorrectly deployed oxygen masks, and cause occupant distress and delayed access to oxygen supply during a high altitude emergency.
Comply with this AD within the compliance times specified, unless already done.
(1) For Model CL-600-2B19 airplanes equipped with oxygen box assembly part number (P/N) 3868301 or 3868302 with C&D
(2) For airplane Model CL-600-2C10, S/N 10003 through 10346 inclusive; Models CL-600-2D15 and CL-600-2D24, S/N 15001 through 15436 inclusive; and Model CL-600-2E25, S/N 19001 through 19055 inclusive; equipped with oxygen box assembly P/N 9324601[ ]505/507/509/511, 9324614[ ]505/509, D114601[ ]501/503/505/507/509, D114602[ ]503/507/511, or D114603[ ]501 (where “[ ]” indicates the décor finish code letters): Within 8,800 flight hours or 48 months, whichever is first, after the effective date of this AD, repack the assembly, replace the packaging placard, and re-identify the assembly in accordance with paragraphs 2.A. and 2.B. of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-35-015, dated October 30, 2017.
For Model CL-600-2C10, CL-600-2D15, CL-600-2D24, and CL-600-2E25 airplanes: After accomplishment of the actions required by paragraph (g)(2) of this AD, if applicable, or within 30 days after the effective date of this AD, whichever is later, no one may operate any airplane with oxygen box assemblies packed using Bombardier Aircraft Maintenance Manual (AMM) task 35-21-13-860-802, “Repack and Stowage of the Flight Attendant Oxygen Mask,” or 35-21-17-860-802, “Repack of the Passenger Mask in the Lavatory.”
The AMM tasks identified in paragraph (h) of this AD have been superseded by AMM tasks 35-21-13-860-804, “Repack and Stowage of the Forward and Aft Flight Attendant Oxygen-Mask,” 35-21-13-860-806, “Repack and Stowage of the Third Flight Attendant Oxygen-Mask,” and 35-21-17-860-803, “Repack of the Passenger Mask in the Lavatory.”
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2018-03, dated January 19, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Wray Municipal Airport, Wray, CO, to accommodate new area navigation (RNAV) procedures at the airport. This action would ensure the safety and management of instrument flight rules (IFR) operations within the National Airspace System. Additionally, this action proposes to remove Class E airspace extending upward from 1,200 feet above the surface at Wray Municipal Airport, Wray, CO. This airspace is wholly contained within the Denver en route airspace area and duplication is not necessary.
Comments must be received on or before July 26, 2019.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2019-0371; Airspace Docket No. 17-ANM-6, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Matthew Van Der Wal, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3695.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A,
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2019-0371; Airspace Docket No. 17-ANM-6”. The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface at Wray Municipal Airport, Wray, CO, within 1 mile each side of the 180° bearing extending from the 6.5 mile radius to 11 miles south of the airport and 2 miles each side of the 360° bearing extending from the 6.5 mile radius to 10.8 miles north of the airport. Additionally, this action proposes to remove Class E airspace extending upward from 1,200 feet above the surface at Wray Municipal Airport, Wray, CO. This airspace is wholly contained within the Denver en route airspace area and duplication is not necessary.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5 mile radius of the airport, and within 1 mile each side of the 180° bearing extending from the 6.5 mile radius to 11 miles south of the airport, and within 2 miles each side of the 360° bearing extending from the 6.5 mile radius to 10.8 miles north of the Wray Municipal Airport.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Maine for purposes of implementing the 2008 Ozone National Ambient Air Quality Standards (NAAQS). The revisions consist of a demonstration that Maine meets the requirements of reasonably available control technology (RACT) for volatile organic compounds (VOCs), set forth by the Clean Air Act (CAA or Act), with respect to the 2008 Ozone standards. Additionally, we are proposing to approve a related regulation that limits air emissions of VOCs from certain industrial sources that use organic solvents in cleaning activities, and to withdraw several previously approved source-specific RACT requirements for sources that have ceased operation. This action is being taken under the Clean Air Act.
Written comments must be received on or before July 11, 2019.
Submit your comments, identified by Docket ID No. EPA-R01-OAR-2019-2018 at
David L. Mackintosh, Air Quality Branch, U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office Square—Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel. 617-918-1584, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Maine is part of the Ozone Transport Region (OTR) under Section 184(a) of the CAA. Sections 182(b)(2) and 184 of the CAA require states with Ozone nonattainment areas that are classified as moderate or above, as well as areas in the OTR, to submit a SIP revision requiring the implementation of reasonably available control technology (RACT) for sources covered by a control techniques guideline (CTG) and for all major sources. A CTG is a document issued by EPA which establishes a “presumptive norm” for RACT for a specific VOC source category. RACT is defined as the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.
On October 5, 2006 (71 FR 58745), EPA issued four new CTGs, which applicable areas were required to address by October 5, 2007: Industrial Cleaning Solvents; Offset Lithographic Printing and Letterpress Printing; Flexible Package Printing; and Flat Wood Paneling Coatings. On October 9, 2007 (72 FR 57215), EPA issued three more CTGs, which applicable areas were required to address by October 9, 2008: Paper, Film, and Foil Coatings; Large Appliance Coatings; and Metal Furniture Coatings. On October 7, 2008 (73 FR 58841), EPA issued an additional four CTGs, which applicable areas were required to address by October 7, 2009: Miscellaneous Metal and Plastic Parts Coatings; Fiberglass Boat Manufacturing Materials; Miscellaneous Industrial Adhesives; and Automobile and Light-Duty Truck Assembly Coatings. Lastly, on Oct 27, 2016 (81 FR 74798), EPA issued a new CTG for the Oil and Natural Gas Industry, which applicable areas were required to address by October 27, 2018.
On March 27, 2008 (73 FR 16436), EPA revised the health-based NAAQS for Ozone to 0.075 parts per million (ppm), averaged over an 8-hour timeframe. EPA determined that the revised 8-hour standard would be more protective of human health, especially with regard to children and adults who are active outdoors and individuals with a pre-existing respiratory disease such as asthma.
On July 29, 2014 (79 FR 43945), EPA published a final rule approving a request from Maine for an exemption from the requirements for the control of nitrogen oxides (NO
On March 6, 2015 (80 FR 12264), EPA published a final rule outlining RACT requirements and requiring states in the OTR to certify RACT requirements by July 20, 2014. This rule, referred to as the “2008 Ozone implementation rule,”
On October 26, 2015 (80 FR 65291), EPA revised the health-based NAAQS for Ozone, setting it at 0.070 ppm averaged over an 8-hour time frame. On December 6, 2018 (83 FR 62998), EPA published a final rule that outlines the obligations for areas in nonattainment with the 2015 Ozone standard, as well as obligations for areas in the OTR. This rule, referred to as the “2015 Ozone implementation rule,” requires states in the OTR to certify RACT requirements by August 3, 2020.
On February 3, 2017 (82 FR 9158), EPA published a final rule finding that Maine, as well as 14 other states and the District of Columbia, had failed to submit SIP revisions in a timely manner to satisfy certain requirements for the 2008 Ozone NAAQS. With respect to Maine, EPA found that the state had failed to submit two required SIP elements: Non-CTG VOC RACT for Major Sources and CTG VOC RACT.
On August 31, 2018, Maine submitted a SIP revision to address its outstanding RACT requirements for the 2008 Ozone NAAQS (
On September 4, 2018, EPA determined that Maine's SIP submittal was administratively and technically complete. This determination stopped the 18-month sanctions clock for Maine's two outstanding RACT SIP submittal elements. Because the sanctions clock stopped before September 6, 2018, sanctions did not become applicable in the state of Maine from the February 2017 finding of failure to submit (82 FR 9158).
On May 13, 2019, Maine modified its August 2018 SIP revision by letter in which it withdrew an item in the submitted SIP Revision. Specifically, on Table 3, “Previously-Approved RACT Determinations for Major Sources of VOC in Maine Now Permanently Closed or No Longer Subject to RACT,” Maine withdrew (
Maine's August 2018 SIP submittal does not address RACT requirements for the 2015 Ozone standard, or the 2016 CTG for the Oil and Natural Gas Industry and, therefore, these are not addressed in today's notice.
In Maine's August 2018 SIP revision, Table 1 lists each of the state's VOC RACT regulations, the RACT basis for the regulation (
Maine's August 2018 submittal also included negative declarations for the following CTG source categories: Auto and Light-Duty Truck Assembly Coatings; Equipment Leaks from Natural Gas/Gasoline Processing Plants; Fugitive Emissions from Synthetic Organic Chemical Polymer and Resin Manufacturing Equipment; Large Petroleum Dry Cleaners; Leaks from Petroleum Refinery Equipment; Manufacture of High-Density Polyethylene, Polypropylene, and Polystyrene Resins; Manufacture of Pneumatic Rubber Tires; Manufacture of Synthesized Pharmaceutical Products; Manufacturing of Vegetable Oil; Petroleum Liquid Storage in External Floating Roof Tanks; Refinery Vacuum Producing Systems, Wastewater Separators, and Process Unit Turnarounds; SOCMI Air Oxidation
Maine's new regulation 06-096 CMR Chapter 166, “Industrial Cleaning Solvents,” expands the types of VOC emissions controlled for industrial cleaning solvents to address the 2006 Industrial Cleaning Solvents CTG. The regulation generally applies to an owner or operator of a source that uses industrial cleaning solvents in cleaning activities and, before controls, creates actual emissions of 3 tons or more of VOC from cleaning activities during any calendar year. As described in the regulation, exemptions can apply to cleaning activities regulated by another source category. The emission limits are achieved by (1) using solvents with a maximum VOC content limit of 50 grams VOC per liter (0.42 lg/gal), (2) using cleaning solvents with a composite vapor pressure of 8.0 millimeters or less of mercury (mm Hg) at 20 degrees Celsius, or (3) using an emission control system with an overall control efficiency of at least 85 percent. Recordkeeping and general work practices are also required for applicable sources. These provisions are consistent with EPA's recommendations for such sources in the 2006 Industrial Cleaning Solvents CTG. Thus, EPA proposes to approve Chapter 166 into the Maine SIP. Adding this regulation to the SIP satisfies the anti-backsliding requirements of Section 110(
Section 184(b)(2) of the CAA requires RACT be applied to any major existing stationary source with the potential to emit 50 tons or greater per year of VOC. Maine's Chapter 134, “RACT for Facilities that Emit VOCs,” rule generally applies to Maine sources with potential VOC emissions of 40 tons per year or greater that are not regulated by a specific regulation. In 2012 (77 FR 30216), EPA approved Chapter 134 as meeting RACT requirements for the 1997 Ozone NAAQS. EPA proposes that Chapter 134 continues to represent RACT for applicable major stationary sources of VOCs in Maine for the 2008 Ozone standard.
Maine's EPA-approved Chapter 134 establishes several RACT options, two of which set presumptive standards for VOC emissions reductions and a third that allows a source to submit a variety of strategies as an alternative compliance plan to reduce VOC emissions. Because the third option describes a process by which RACT can be defined but does not define RACT as required by the CAA, Maine must submit source-specific requirements to EPA for all applicable sources that do not conform to the presumptive RACT options outlined in the rule. EPA has approved many such source-specific RACT determinations into the SIP.
Chapter 134 also includes provisions that exempt certain sources from additional control requirements, such as for equipment or processes that have met best available control technology (BACT), have met lowest achievable emission rate (LAER), or are subject to a separate RACT rule adopted by Maine and approved by EPA. Chapter 134 also exempts indirect contact wood kilns and wood yards (but not groundwood operations) from requirements for additional controls because it would not be technologically or economically practical to attempt to enclose these areas and capture VOCs and route them to a control device.
Table 2 of Maine's SIP revision lists the major VOC sources in Maine, along with their licensed (potential to emit) VOC emissions, and notes which sources are subject to applicable RACT requirements and which facilities have VOC-emitting equipment or processes that are exempt from the total VOC emission determination in Chapter 134. After reviewing existing stationary sources in Maine, the state determined that all major sources of VOC are currently meeting RACT requirements. EPA proposes that Chapter 134 and the previously-approved source-specific determinations continue to represent RACT for these VOC sources in Maine for the 2008 Ozone standard because no new control technologies are known to be reasonably available considering technological and economic feasibility for these sources since our last approval.
As explained above, Chapter 134 includes a process whereby a major VOC source in Maine may seek a source-specific RACT determination rather than be held to the specific emission limits or technology standards that are set forth in the rule. Because of the generic nature of this provision, RACT determinations established thereunder are submitted to EPA as revisions to Maine's SIP. Over the years, EPA has approved a number of such source-specific RACT determinations into the Maine SIP. Several of the sources that have received such RACT determinations are now either permanently closed or have ceased operations of the regulated activity. In its August 2018 submittal, Maine requested withdrawal of these previously SIP-approved source-specific requirements. Six facilities have permanently closed: (1) Prime Tanning Company, York County, Berwick, Maine; (2) JJ Nissen Baking Company, Cumberland County, Portland, Maine; (3) Georgia Pacific Corporation, Washington County, Baileyville (Woodland), Maine; (4) Moosehead Manufacturing Company, Piscataquis County, Dover-Foxcroft, Maine; (5) Moosehead Manufacturing Company, Piscataquis County, Monson, Maine; and (6) Dexter Shoe Company, Penobscot County, Dexter, Maine. A seventh facility—the McCain Foods USA, Inc., Tatermeal Facility in Presque Isle—surrendered its license to operate its dryers used to dehydrate primarily potato wastes to produce a material used as a binder and nutritional supplement in animal feed. EPA proposes to remove from the Maine SIP the source-specific RACT requirements associated with these sources because the sources are permanently closed or have ceased operations of the regulated activity and are, therefore, no longer sources of emissions subject to non-CTG VOC RACT. Withdrawing these requirements from the Maine SIP satisfies the anti-backsliding requirements in Section 110(
EPA is proposing to approve 06-096 CMR Chapter 166, “Industrial Cleaning Solvents,” into the Maine SIP at 40 CFR 52.1020(c), “EPA approved regulations.” EPA is proposing to approve Maine's SIP revision on the basis that Maine has met the RACT
EPA is proposing to withdraw the following previously-approved source-specific RACT requirements for “Prime Tanning Company, York County, Berwick, Maine” (two approvals); “JJ Nissen Baking Company, Cumberland County, Portland Maine”; “Georgia Pacific Corporation, Washington County, Woodland, Maine”; “Moosehead Manufacturing Company, Piscataquis County, Dover-Foxcroft, Maine”; “Moosehead Manufacturing Company, Piscataquis County, Monson, Maine”; “Dexter Shoe Company, Penobscot County, Dexter, Maine” (two approvals); and “McCain Foods USA, Inc., Tatermeal Facility”, and to remove all entries for these facilities which are currently listed in 40 CFR 52.1020(d) “EPA-approved State Source specific requirements.”
EPA is not proposing action with respect to the 2015 Ozone NAAQS or with respect to the 2016 CTG for Oil and Natural Gas Industry. EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to this proposed rule by following the instructions listed in the
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference “Reasonably Available Control Technology (RACT) State Implementation Plan (SIP) Revision Under the 2008 8-Hour Ozone National Ambient Air Quality Standard (NAAQS),” and 06-096 CMR Chapter 166, “Industrial Cleaning Solvents.” The EPA has made, and will continue to make, these documents generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to approve revisions to the Alaska State Implementation Plan (SIP) submitted on October 25, 2018. The revisions adopt changes to federal emissions factors and modeling guidelines, update pre-construction permitting of stationary sources, and fix typographical and grammatical errors. Upon final approval, the Alaska SIP will include provisions for electronic permit applications, online notice of draft permits, revised modeling guidelines, and updated fine particulate matter requirements in nonattainment areas. The EPA also proposes to approve the submitted revisions as meeting major source pre-construction permitting requirements for the Fairbanks North Star Borough fine particulate matter nonattainment area.
Comments must be received on or before July 11, 2019.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2018-0809, at
Kristin Hall at (206) 553-6357,
Throughout this document, wherever “we,” “us,” or “our” is used, it means the EPA.
Section 110 of the Clean Air Act (CAA) governs the process by which a state submits air quality protection requirements to the EPA for approval into the State Implementation Plan (SIP). The SIP is the state's plan to implement, maintain, and enforce the National Ambient Air Quality Standards (NAAQS) set by the EPA. To ensure consistency with federal requirements, Alaska generally submits an annual rule update to the EPA for approval.
On October 25, 2018, the Alaska Department of Environmental Conservation (ADEC) submitted such an update. The submission includes revisions to Alaska Administrative Code, Title 18, Environmental Conservation, Chapter 50, Air Quality Control (18 AAC 50), state effective September 15, 2018. Specifically, the submission updates the dates by which certain EPA regulations are adopted by reference, brings the major stationary source pre-construction permitting program up-to-date with current fine particulate matter (PM
Alaska updated the adoption by reference of federal
Alaska updated the adoption by reference of the federal Guidelines on Air Quality Models, codified at 40 CFR part 51, appendix W (Appendix W), as of July 1, 2017.
Alaska's major new source review (major NSR) program implements pre-construction permitting for new and modified major stationary sources. The major NSR program is established in Article 3 of 18 AAC 50, and references supporting rules throughout the Alaska SIP. To make it easier to keep the program up-to-date, Alaska's major NSR program incorporates by reference certain federal NSR regulations as of a specific date, and the state routinely updates this citation date.
Alaska's major NSR program, established in Article 3 of 18 AAC 50, includes PSD and NNSR. Alaska's PSD program is governed by 18 AAC 50.306 and refers to 18 AAC 50.040(h), which adopts certain provisions of 40 CFR 51.166 and 40 CFR 52.21 by reference.
Alaska also requested approval of a provision allowing ADEC to require owners and operators of certain minor stationary sources to apply for their permits online, through Alaska's Online System/Permittee Portal.
Alaska has a SIP-approved major NNSR program applicable in designated PM
Alaska adopted key requirements that the EPA revised in accordance with the D.C. Circuit court's decision, including the definitions for “major source,” “regulated NSR pollutant,” and “significant,” as these definitions apply in PM
Alaska also revised the definition of “significant.” This term is used to evaluate the extent to which construction at an existing major stationary source becomes subject to NNSR as a major modification with respect to the nonattainment pollutant. A major modification, defined in 40 CFR 51.165(a)(1)(v)(A), is any physical change in or change in the method of operation of a major stationary source that would result in: (1) A significant emissions increase of a regulated NSR pollutant, and (2) a significant net emissions increase of that pollutant. “Significant” is separately defined in 40 CFR 51.165(a)(1)(x)(A) to mean a rate of emissions specified for each pollutant or precursor to that pollutant. Alaska defined “significant” in PM
Alaska's only designated PM
In the October 25, 2018 revisions, Alaska set significant emissions rates for all four regulated precursors to PM
Based on the SIP-approved emissions inventories demonstrating no existing major sources of ammonia and extremely low total estimated ammonia emissions from existing stationary sources in the FNSB PM
We propose to approve the submitted revisions to the Alaska PM
The submission clarified requirements for pre-approved stationary source emissions limits. Specifically, the state revised rule language to make clear that if a source terminates a pre-approved limit that had allowed the source to avoid preconstruction review, the limit remains in effect until a minor permit, as well as a construction permit, is issued for the source.
Alaska submitted several corrections to typographical, grammatical, and cross-reference errors. First, Alaska corrected the geographic name of
The EPA proposes to approve, and incorporate by reference, the revisions to the Alaska SIP submitted on October 25, 2018 and described above. Upon final approval, the Alaska SIP will contain the following rule sections, state effective September 15, 2018:
• 18 AAC 50.025
• 18 AAC 50.035
• 18 AAC 50.040
• 18 AAC 50.055
• 18 AAC 50.215
• 18 AAC 50.220
• 18 AAC 50.225
• 18 AAC 50.230
• 18 AAC 50.260
• 18 AAC 50.311
• 18 AAC 50.345
• 18 AAC 50.502
• 18 AAC 50.540
• 18 AAC 50.542
• 18 AAC 50.560
• 18 AAC 50.990
The listed exceptions were not submitted in the October 25, 2018 submission and are not part of the current federally-approved Alaska SIP.
The EPA also proposes to approve the submission as fulfilling NNSR requirements for the FNSB PM
In this rule, the EPA proposes to include in a final rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA proposes to incorporate by reference the provisions described in Section III. The EPA has made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and record keeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Missouri on January 14, 2019. The revision submitted by the state is an amendment to a rule relating to reference methods for determining ambient air/atmosphere data and information necessary for the enforcement of air pollution control regulations throughout Missouri. The revision is administrative in nature and either incorporates by reference or updates state rules to match Federal regulations. This revision does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).
Comments must be received on or before July 11, 2019.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2019-0293 to
Jonathan Meyer, Environmental Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-7140; email address
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-0293, at
The EPA is proposing to approve a revision to Missouri's SIP by approving the state's request to revise 10 CSR 10-6.040,
The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The state provided public notice on this SIP revision from June 25, 2018 to August 2, 2018 and received zero comments. In addition, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
We are proposing to approve the revisions to 10 CSR 6.040
In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Missouri Regulations described in the proposed amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) and Operating Permits Program revision submitted by the State of Missouri on January 15, 2019. The revisions add definitions, removes language referring to outdated emission fees, and updates incorporations by reference in the rule. The revision is administrative in nature and does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).
Comments must be received on or before July 11, 2019.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2019-0300 to
Jonathan Meyer, Environmental Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-7140; email address
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-0300, at
The EPA is proposing to approve a revision to Missouri's SIP by approving the state's request to revise 10 CSR 10-6.110,
• Missouri Emissions Inventory System (MoEIS)—the online interface of the state of Missouri's air emissions inventory database.
• Point source—a large, stationary (nonmobile), identifiable source of emissions that releases pollutants into the atmosphere, that is either a major source under 40 CFR part 70 for the pollutants for which reporting is required; or a holder of an intermediate operating permit.
• Reporting year—Twelve (12) month calendar year ending December 31. The reporting requirement for installations with three (3)-year reporting cycles begins with the 2011 reporting year. The subsequent reporting years will be every three (3) years following 2011 (
• Small source—An installation subject to this rule but not a point
The addition of the above definitions to 10 CSR 10-6.110 provides additional context to requirements of the rule that were not previously defined but do no impact the applicability of the requirements of the rule.
Section (3)(A)1. revised the emission fees section, which is approved under the Operating Permits Program only, and removes language that applied to emissions fees prior to January 1, 2016. No changes were made to the emission fees in the rule.
Section (3)(B) is revised to update incorporation by reference of AP-42 (Environmental Protection Agency Compilation of Air Pollution Emission Factors) as published by the EPA in August 2018 and FIRE (Factor Information Retrieval System) as published by EPA August 2017.
Section (3)(C)4.B. was revised to update incorporation by reference of 40 CFR 52.21 as promulgated by EPA as of July 1, 2018.
Section (4)(C)2. was revised to clarify that an installation that does not submit a full emissions report is required to submit a reduced reporting form. The revised language does not alter the requirements of the rule.
Section (4)(C)7. was removed from the rule and no longer requires revised Emissions Inventory Questionnaires to be presented to the regulated community for a forty-five-day comment period.
The above revisions to 10 CSR 10-6.110 are administrative in nature, update incorporation by reference, or provide additional context to regulatory language without altering applicability of the rule and does not impact air quality. Therefore, the EPA proposes to approve the above revisions to 10 CSR 10-6.110.
The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The state provided public notice on this SIP revision from June 25, 2018, to August 2, 2018, and received comments from the EPA and a regulated entity. The state adequately addressed the public comments. In addition, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
We are proposing to approve the revisions to Missouri's SIP and Missouri's Operating Permits Program by approving the state's request to revise 10 CSR 10-6.110,
In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Missouri Regulations described in the proposed amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Operating permits, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the EPA proposes to amend 40 CFR parts 52 and 70 as set forth below:
42 U.S.C. 7401
(c) * * *
42 U.S.C. 7401,
(hh) The Missouri Department of Natural Resources submitted revisions to Missouri rule 10 CSR 10-6.110, “Reporting Emission Data, Emission Fees, and Process Information” on January 15, 2019. The state effective date is January 30, 2019. Approval of Section 3(A) of 10 CSR 10-6.110 is effective [date 30 days after date of publication of the final rule in the
Environmental Protection Agency (EPA).
Proposed rule.
Ohio has applied to the Environmental Protection Agency (EPA) for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA), as amended. EPA has reviewed Ohio's application and has determined that these changes satisfy all requirements needed to qualify for final authorization. Therefore, we are proposing to authorize the State's changes. EPA seeks public comment prior to taking final action.
Comments must be received on or before July 11, 2019.
Submit your comments by one of the following methods:
•
•
•
•
•
You can view and copy Ohio's application and associated publicly available materials from 9:00 a.m. to 4:00 p.m. at the following locations: U.S. EPA Region 5, LR-17J, 77 West Jackson Boulevard, Chicago, Illinois, contact: Jean Gromnicki (312) 886-6162; or Ohio Environmental Protection Agency, Lazarus Government Center, 50 West Town Street, Suite 700, Columbus, Ohio, contact: Katherine (Kit) Arthur (614) 644-2932.
Submit your comments, identified by Docket ID No. EPA-R05-RCRA-2018-0375 at
Jean Gromnicki, Ohio Regulatory Specialist, U.S. EPA Region 5, LR-17J, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6162, email:
States that have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, states must change their programs and ask EPA to authorize the changes. Changes to state programs may be necessary when Federal or state statutory or regulatory authority is modified or when certain other changes occur. Most commonly, states must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.
New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized states at the same time that they take effect in unauthorized states. Thus, EPA will implement those requirements and prohibitions in Ohio, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.
On February 19, 2019, Ohio submitted a complete program revision application seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between July 1, 1987 and June 30, 2015 (including RCRA Clusters II and XXI through XXIV). EPA concludes that Ohio's application to revise its authorized program meets all of the statutory and regulatory requirements established under RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA proposes to grant Ohio final authorization to operate its hazardous waste program with the changes described in the authorization application, and as outlined below in Section F of this document.
Ohio has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of HSWA, as discussed above.
If Ohio is authorized for the changes described in Ohio's authorization application, these changes will become part of the authorized State hazardous waste program, and will therefore be federally enforceable. Ohio will continue to have primary enforcement authority and responsibility for its State hazardous waste program. EPA would maintain its authorities under RCRA sections 3007, 3008, 3013, and 7003, including its authority to:
• Conduct inspections, and require monitoring, tests, analyses and reports;
• Enforce RCRA requirements, including authorized State program requirements, and suspend or revoke permits; and
• Take enforcement actions regardless of whether the State has taken its own actions.
This action will not impose additional requirements on the regulated community because the regulations which EPA is proposing to authorize Ohio are already effective under state law, and are not changed by today's proposed action.
If EPA receives comments on this proposed action, we will address all such comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you should do so at this time.
Ohio initially received final authorization on June 28, 1989, effective June 30, 1989 (54 FR 27170, June 28, 1989) to implement the RCRA hazardous waste management program. Subsequently the EPA granted authorization for changes to the Ohio program effective June 7, 1991 (56 FR 14203, April 8, 1991) as corrected June 19, 1991, effective August 19, 1991 (56 FR 28088); effective September 25, 1995 (60 FR 38502. July 27, 1995); effective December 23, 1996 (61 FR 54950, October 23, 1996); effective January 24, 2003 (68 FR 3429, January 24, 2003); effective January 20, 2006 (71 FR 3220, January 20, 2006); effective October 29, 2007 (72 FR 61063, October 29, 2007); effective March 19, 2012 (77 FR 25966, March 19, 2012), and effective February 12, 2018 (83 FR 5948, February 12, 2018).
On February 19, 2019, Ohio submitted a final complete program revision application, seeking authorization of changes to its hazardous waste management program in accordance with 40 CFR 271.21. EPA proposes to determine, subject to receipt of written comments that oppose this action, that Ohio's hazardous waste program revisions are equivalent to, consistent with, and no less stringent than the federal program, and therefore satisfy all of the requirements necessary to qualify
Ohio has excluded the non-delegable federal requirements at 40 CFR 268.5, 268.6, 268.42(b), 268.44, and 270.3. EPA will continue to implement those requirements. Only recently receiving the statutory authority, Ohio has not adopted the rules for Subparts AA, BB and CC of 40 CFR part 264. Until Ohio is authorized for such rules, the federal rules at 40 CFR part 264 subpart AA, BB and CC and Part 265 subpart AA, BB and CC, which are promulgated under HSWA, still apply in Ohio.
Ohio has added three new types of Universal Waste (UW) to their existing UW Rule. They are Paint and Paint-Related Waste, Antifreeze and Non-Empty Aerosol Containers that are not already regulated as hazardous waste. Since Ohio is adding universal wastes EPA does not regulate under RCRA subtitle C, these additions are considered broader in scope and, as noted above, Ohio is not seeking authorization for them.
When the Final Authorization takes effect, Ohio will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which EPA issues prior to the effective date of the proposed authorization until they expire or are terminated. EPA will not issue any new permits or new portions of permits for the provisions listed in the Table above after the effective date of the authorization. EPA will continue to
Ohio is not authorized to carry out its hazardous waste program in Indian country within the State, which includes:
• All lands within the exterior boundaries of Indian reservations within or abutting the State of Ohio;
• Any land held in trust by the U.S. for an Indian tribe; and
• Any other land, whether on or off an Indian reservation, that qualifies as Indian country.
Therefore, this action has no effect on Indian country. EPA retains jurisdiction over Indian country and will continue to implement and administer the RCRA program on these lands.
Codification is the process of placing citations and references to the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by adding those citations and references to the authorized State rules in 40 CFR part 272. EPA is not proposing to codify the authorization of Ohio's changes at this time. However, EPA reserves the ability to amend 40 CFR part 272, subpart KK for the authorization of Ohio's program changes at a later date.
The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). This action proposes to authorize State requirements for the purpose of RCRA section 3006 and imposes no additional requirements beyond those imposed by State law. Therefore, this action is not subject to review by OMB. This action is not an Executive Order 13771 (82 FR 9339, February 3, 2017) regulatory action because actions such as today's proposed authorization of Ohio's revised hazardous waste program under RCRA are exempted under Executive Order 12866. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Under RCRA section 3006(b), EPA grants a state's application for authorization as long as the state meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a state authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in proposing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of this action in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.
This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended, 42 U.S.C. 6912(a), 6926, and 6974(b).
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 8 chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these 8 chemical substances for an activity that is designated as a significant new use by this proposed rule. If this proposed rule is made final, persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any actions as are required as a result of that determination.
Comments must be received on or before July 11, 2019.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0263, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these proposed SNURs would need to certify their compliance with the SNUR requirements should these proposed rules be finalized. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after July 11, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
1.
2.
EPA is proposing these SNURs under TSCA section 5(a)(2) for 8 chemical substances which were the subjects of PMNs P-16-425, P-18-125, P-18-228, P-18-234, P-18-270, P-18-322, P-19-4, and P-19-34. These proposed SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
The record for the proposed SNURs on these chemicals was established as docket EPA-HQ-OPPT-2019-0263. That record includes information considered by the Agency in developing these proposed SNURs.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i) (15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. TSCA prohibits such manufacturing or processing from commencing until EPA has conducted a review of the SNUN, made an appropriate determination on the SNUN, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute significant new uses for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is proposing significant new use and recordkeeping requirements for 8 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Basis for the SNUR.
• Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
This information may include testing not required to be conducted but which would help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VII. for more information.
• CFR citation assigned in the regulatory text section of these proposed rules.
The regulatory text section of these proposed rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI.
The chemical substances that are the subject of these proposed SNURs are undergoing premanufacture review. EPA has initially determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from the intended conditions of use described in the PMNs could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. Consequently, EPA is proposing to designate these changes as significant new uses.
1. Use other than as a chemical intermediate.
The proposed SNUR would designate as a “significant new use” the absence of this protective measure.
1. No manufacture of the PMN substance in the United States (
2. No use other than the confidential use described in the PMN.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. No use other than the confidential use identified in the PMN; and
2. No manufacture, processing or use of the PMN substance in any manner that results in inhalation exposures.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. No use of the PMN substance involving spray application that results in inhalation exposures.
The proposed SNUR would designate as a “significant new use” the absence of this protective measure.
1. No use of the PMN substance for other than the uses described in the PMN; and
2. No use of the PMN substance in a consumer product.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. No manufacture of the PMN substance in the United States (
2. No processing (formulation) to a concentration of greater than 5% of the PMN substance by weight.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. No manufacture, processing or use of the PMN substance in any manner that results in inhalation exposures.
The proposed SNUR would designate as a “significant new use” the absence of this protective measures.
1. No manufacture of the PMN substance in the United States (
2. No use other than the confidential use described in the PMN including the engineering controls for processing and use as described in the PMN.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
During review of the PMNs submitted for the chemical substances that are the subject of these proposed SNURs and as further discussed in Unit IV, EPA identified certain reasonably foreseen changes from the conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances.
EPA is proposing SNURs for 8 specific chemical substances which are undergoing premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses that would be designated in this proposed rule:
• EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA would be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
Issuance of a proposed SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule were undergoing premanufacture review at the time of signature of this proposed rule and were not on the TSCA Inventory. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to these proposed SNURs, EPA concludes that the proposed significant new uses are not ongoing.
EPA designates June 6, 2019 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.
Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under section 5 allowing manufacture or processing to proceed.
EPA recognizes that TSCA section 5 does not require development of any particular new information (
In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2019-0263.
Additional information about these statutes and Executive Orders can be found at
This proposed rule would establish SNURs for 8 new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).
According to the PRA, 44 U.S.C. 3501
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this proposed rule. As such, EPA has determined that this proposed rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538
This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this proposed rule.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
In addition, since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR part 721 be amended as follows:
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as aromatic dianhydride, polymer with aromatic diamine and heteroatom bridged aromatic diamine, reaction products with aromatic anhydride (P-19-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
Centers for Medicare & Medicaid Services (CMS), HHS.
Extension of timeline for publication of a final rule.
This document announces the extension of the timeline for publication of the “Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care” final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the
As of June 7, 2019, the timeline for publication of the final rule to finalize the provisions of the June 16, 2016 proposed rule (81 FR 39447) is extended until June 16, 2020.
CAPT Scott Cooper, USPHS, (410) 786-9465.
Section 1871(a)(3)(A) of the Social Security Act (the Act) requires the Secretary of the Department of Health and Human Services (the Secretary), in consultation with the Director of the Office of Management and Budget (OMB), to establish a regular timeline for the publication of a final rule based on the previous publication of a proposed rule or an interim final rule.
Section 1871(a)(3)(B) of the Act allows the timeline for publishing Medicare final regulations to vary based on the complexity of the regulation, the number and scope of comments received, and other related factors. The timeline for publishing the final rule, however, cannot exceed 3 years from the date of publishing the proposed regulation unless there are exceptional circumstances. The Secretary may extend the initial targeted publication date of the final rule if the Secretary provides public notice thereof, including a brief explanation of the justification for the variation, no later than the rule's previously established proposed publication date.
After consultation with the Director of OMB, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), published a notice in the December 30, 2004
Sections 1861(e)(1) through (8) of the Act provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals furnished services in the institution. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR part 482, Conditions of Participation (CoPs) for Hospitals. Section 1905(a) of the Act provides that Medicaid payments from States may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii) and § 440.20(a)(3)(ii), hospitals are required to meet the Medicare CoPs in order to participate in Medicaid.
On May 26, 1993, CMS published a final rule in the
Sections 1820 and 1861(mm) of the Act, as amended by section 4201 of the Balanced Budget Act (BBA) of 1997, replaced the EACH/RPCH program with the Medicare Rural Hospital Flexibility Program (MRHFP), under which a qualifying facility can be designated and certified as a Critical Access Hospital (CAH). CAHs participating in the MRHFP must meet the conditions for designation specified in the statute under section 1820(c)(2)(B) of the Act, and to be certified must also meet other criteria the Secretary may require, under section 1820(e)(3) of the Act. Under this authority, the Secretary has established regulatory requirements that a CAH must meet to participate in Medicare at 42 CFR part 485, subpart F.
In the June 16, 2016
The revisions contained in the June 16, 2016 proposed rule were intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns. In response to the proposed rule, we received 200 public comments. Commenters included individuals, healthcare professionals and corporations, national associations and coalitions, state health departments, patient advocacy organizations, and individual facilities that would be impacted by the regulation. Generally, most comments centered on expressing
This document announces an extension of the timeline for publication of the final rule due to exceptional circumstances. We were not able to meet the 3-year timeline for the publication of the final rule due to the complexity and substantive nature of the provisions proposed in the June 16, 2016 proposed rule. Additional time is needed to fully consider all the comments and provisions, and to ensure that we most appropriately modernize and revise the requirements of the CoPs for hospitals and CAHs. Some of these proposed changes include provisions to address—(1) use of the term “Licensed Independent Practitioners;” (2) requirements that do not fully conform to current standards for infection control; (3) requirements for antibiotic stewardship programs to help reduce inappropriate antibiotic use and antimicrobial resistance; (4) the use of quality reporting program data by hospital QAPI programs; (5) a new requirement for CAHs that mirrors the existing QAPI requirements for hospitals; and (6) a new provision that would allow CAHs to grant qualified dietitians and nutrition professionals ordering privileges for dietary services, mirroring an existing provision in the hospital CoPs.
As stated in the Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (
We stress that our decision in this matter to extend the timeline for issuing a final rule should not be viewed as a diminution of the Department's commitment to timely and effective rulemaking. Our goal remains to publish, as expeditiously as feasible, a final rule that supports improvements in the quality of patient care through adoption of current standards of practice, while also minimizing the burden on providers to the maximum possible extent. At this time, we believe we can best achieve this balance by issuing this continuation document.
Therefore, this document extends the timeline to finalize the provisions in the June 16, 2016 proposed rule for 1 year, until June 16, 2020.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the OMB under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare & Medicaid Services (CMS), HHS; Department of the Treasury.
Request for information.
CMS is committed to transforming the health care delivery system—and the Medicare and Medicaid programs—by putting additional focus on patient-centered care, innovation, and outcomes. As part of our continuing Patients over Paperwork initiative, we have actively solicited feedback from the medical community through Requests for Information (RFIs), listening sessions, and clinical onsite engagements with front-line clinicians and staff to learn how our administrative requirements and processes affect their daily work and ability to innovate in care delivery. This RFI solicits additional public comment on ideas for regulatory, subregulatory, policy, practice, and procedural changes that reduce unnecessary administrative burdens for clinicians, providers, patients and their families. Through these efforts, we aim to increase quality of care, lower costs, improve program integrity, and make the health care system more effective, simple, and accessible.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 12, 2019.
In commenting, refer to file code CMS-6082-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Morgan Taylor, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (410) 786-3458.
Mary G. Greene, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (410) 786-1244.
CMS is committed to transforming the health care delivery system—and the Medicare and Medicaid programs—by putting additional focus on patient-centered care, innovation, and outcomes. Our top priority is putting patients first and empowering them to make the best decisions for themselves and their families. Our continued goal is to eliminate overly burdensome and unnecessary regulations and subregulatory guidance in order to allow clinicians and providers to spend less time on paperwork and more time on their primary mission—improving their patients' health. We are also modernizing or eliminating outdated regulations to remove barriers to innovation. By reducing unnecessary paperwork, we are unleashing the most powerful force in our healthcare system for improving health outcomes: The clinician-patient relationship.
We launched our Patients over Paperwork initiative in 2017 to focus all of CMS on finding opportunities to modernize or eliminate rules and requirements that are outdated, duplicative, or getting in the way of good patient care. Public input has been critical to CMS achieving more flexibilities and efficiencies. As part of the Patients over Paperwork initiative, we actively solicited feedback from the medical community through requests for information (RFI), listening sessions, and clinical onsite engagements with front-line clinicians and staff to learn how our administrative requirements and processes affect their daily work and ability to innovate in care delivery. Through the RFI process alone, we received over 3,000 responses that outlined current burden and recommendations, which resulted in 1,146 distinct burden topics to address. Topics included, but were not limited to: Audits and Claims; Documentation Requirements; Health Information Technology; Interoperability; Provider Participation Requirements; Quality Measures and Reporting; Payment Policy and Coverage Determinations; the Physician Self-Referral Law; and Telehealth.
Over 2,000 clinicians, administrative staff and leaders, and beneficiaries have participated in our listening sessions and onsite engagements and we continue to send teams out into the field to learn more. This fieldwork helped elucidate how our rules affect workflow and decision-making, and potentially impede innovation. As of February 8, 2019, after reviewing and adjudicating all 1,146 burden topics with executive leadership across the agency, we have resolved or are actively addressing over 80 percent of the actionable RFI burden topics through changes to our regulations, subregulatory guidance, operations, or direct education and outreach to providers and beneficiaries. Please see the Appendix for a sample of what we have accomplished so far.
As we continue to work to maintain flexibility and efficiency throughout the Medicare and Medicaid programs, we would like to continue our national conversation about improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, providers, and patients and their families. Through these efforts, we aim to increase quality of care, lower costs, improve program integrity, and make the health care system more effective, simple, and accessible. For these reasons, we are seeking comments on additional opportunities for improvement through this RFI.
We invite the public to submit ideas for regulatory, subregulatory, policy, practice, and procedural changes to better accomplish these goals. Specifically, we are soliciting new ideas not conveyed during our first RFI on this matter and innovative ideas that may help broaden perspectives about potential solutions. Ideas may include, but are not limited to:
• Modification or streamlining of reporting requirements, documentation requirements, or processes to monitor compliance to CMS rules and regulations;
• Aligning of Medicare, Medicaid and other payer coding, payment and documentation requirements, and processes;
• Enabling of operational flexibility, feedback mechanisms, and data sharing that would enhance patient care, support the clinician-patient relationship, and facilitate individual preferences; and
• New recommendations regarding when and how CMS issues regulations and policies and how CMS can simplify rules and policies for beneficiaries, clinicians, and providers.
We are particularly interested in recommendations on how CMS could:
• Improve the accessibility and presentation of CMS requirements for quality reporting, coverage, documentation, or prior-authorization;
• Address specific policies or requirements that are overly burdensome, not achievable, or cause unintended consequences in a rural setting;
• Clarify or simplify regulations or operations that pose challenges for beneficiaries dually enrolled in both Medicare and Medicaid and those who care for such beneficiaries; and
• Simplify beneficiary enrollment and eligibility determination across programs.
We are requesting respondents provide complete, clear, and concise comments that include, where practicable, data and specific examples.
Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
We note that this is a RFI only. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This RFI does not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through this RFI and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. We note that not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI
We will actively consider all input as we develop future regulatory proposals or future subregulatory policy guidance. We may or may not choose to contact individual responders. Such communications would be for the sole purpose of clarifying statements in the responders' written responses. Contractor support personnel may be used to review responses to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. In addition, we may publically post the public comments received, or a summary of those public comments.
The following is a sample of CMS accomplishments reducing unnecessary administrative burden in response to input from clinicians, providers, beneficiaries, and other stakeholders. For more Patients over Paperwork highlights, visit
• Removed data elements from the Outcomes and Assessment Information Set (OASIS) assessment instrument.
• Removed the inpatient admission order documentation requirement in an effort to reduce duplicative documentation requirements at the time of admission.
• Removed the requirement that certification/recertification statements detail where in the medical record the required information can be found.
• Established the innovative new classification system, the Patient Driven Payment Model (PDPM), that ties skilled nursing facility payments to patients' conditions and care needs rather than volume of services provided, and simplifies complicated paperwork requirements for performing patient assessments by significantly reducing reporting burden.
• Eliminated the requirement that certifying physicians estimate how much longer skilled services are required when recertifying the need for continued home health care.
• Proposed giving facilities the flexibility to review their emergency program every 2 years, or more often at their own discretion, in order to best address their individual needs.
• Proposed allowing multi-hospital systems to have unified and integrated Quality Assessment and Performance Improvement (QAPI) and unified infection control programs for all of its member hospitals.
• Published a proposed rule to streamline Medicaid & CHIP managed care regulation.
• Issued Medicare Advantage (MA) and the prescription drug benefit program (Part D) final rule that promotes innovation, empowers patients and providers to make healthcare decisions, and includes burden-reducing provisions.
• Changed policy to allow a teaching physician to rely on medical student documentation and verify it rather than re-documenting the evaluation and management (E&M) service, and explained that the physician's signature and date is acceptable verification of the medical student's documentation.
• Provided an exception so that physicians acting as suppliers do not need to write orders to themselves.
• Simplified the requirements for preliminary/verbal Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) orders: Suppliers may dispense most items of DMEPOS based on a verbal order or preliminary written order from the treating physician.
• Clarified DMEPOS written order prior to delivery date requirements: If the written order is dated the day of or prior to delivery, there is no need for affirmative documentation of it being “received”.
• Clarified that a supplier can use the discharge date as the date of service if mailing 1 or 2 days before discharge.
• Released a newly revised Skilled Nursing Facility Advanced Beneficiary Notice (SNFABN) with concise instructions and no longer using the 5 denial letters and Notice of Exclusion from Medicare Benefits—SNF.
• Our Meaningful Measures initiative is centered on holding providers accountable for patient health outcomes, safe and efficient care, and making sure the measure sets providers are asked to report on are meaningful to patients and clinicians alike.
• Reduced the burden of reporting quality measures in MIPS with a focus on reporting through electronic means and incentivizing the use of clinical registries.
• In implementing the Quality Payment Program (QPP), established a consolidated data submission experience for the different performance categories of the Merit-based Incentive Payment System (MIPS) so that clinicians no longer need to submit data in multiple systems as under the legacy programs (the Physician Quality Reporting System (PQRS) and the Medicare Electronic Health Record (EHR) Incentive Program).
• Refocused the Medicare EHR Incentive Program (now called the Promoting Interoperability Program) on interoperability, emphasizing exchange of health information between patients and providers.
• Implemented changes resulting in faster processing of state requests to make program or benefit changes to their Medicaid program through the state plan amendment (SPA) and section 1915 waiver review process.
Made significant changes to the Medicare Program Integrity Manual Chapter 13 to improve transparency in the Local Coverage Determination process. The manual includes instructions, policies and procedures for Medicare Administrative Contractors (MAC) that administer the Medicare program in different regions of the country, as well as guidance for stakeholder engagement in the process.
• In the Bundled Payments for Care Improvement Advanced (BPCI Advanced) model, CMS issued the Post-Discharge Home Visit Payment Policy waiver which allows for certain services to be delivered in the eligible model beneficiary's home by auxiliary personnel under the general supervision of a participating practitioner.
• In the Next Generation Accountable Care Organization (Next Gen ACO) model, CMS issued the Telehealth Expansion waiver which allows for eligible model beneficiaries to receive Telehealth services in their home.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of proposed FMP Amendment; request for comments.
NMFS announces that the Pacific Fishery Management Council submitted Amendment 28 to the Pacific Coast Groundfish Fishery Management Plan to the Secretary of Commerce for review. If approved, Amendment 28 would establish new and revised areas closed to bottom trawling to conserve and protect Pacific coast groundfish essential fish habitat, and would re-open areas that were closed to bottom trawling to rebuild previously-overfished groundfish stocks. Combined, these two changes are anticipated to increase protections for groundfish essential fish habitat and provide additional flexibility to participants fishing with bottom trawl gear in the groundfish trawl rationalization program. Amendment 28 would also close deep-water areas off the coast of California to bottom contacting gear to protect deep-water habitats, including deep-sea corals using discretionary fishery management plan provisions in the Magnuson-Stevens Fishery Conservation and Management Act.
Comments on Amendment 28 must be received on or before August 10, 2019.
You may submit comments on this document, identified by NOAA-NMFS-2019-0039, by any of the following methods:
•
•
FMP Amendment 28, background information and documents are available at the Council's website at
Gretchen Hanshew, phone: 206-526-6147, or email:
NMFS manages the groundfish fisheries in the exclusive economic zone off Washington, Oregon, and California under the Pacific Coast Groundfish Fishery Management Plan (FMP). The Council prepared and NMFS implemented the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
Amendment 28 would: (1) Revise, or create new area closures to conserve and protect essential fish habitat (EFH) from the adverse effects of bottom trawl fishing activities; (2) re-open historically important fishing grounds to bottom trawl gear to provide additional flexibility in harvest strategies in the Trawl Rationalization Program; (3) close to fishing with bottom contact gear the area of the exclusive economic zone (EEZ) seaward of 3,500 meters under the Magnuson-Stevens Act discretionary authority to protect deep-water habitats, including deep-sea corals; and (4) update information in the FMP regarding designated EFH and the EFH review process.
Using the best scientific information available from the periodic review of groundfish EFH, the Council recommended changes to spatial management measures for vessels fishing with bottom trawl gear or bottom contact gear; primarily changes to EFH conservation area (EFHCA) boundaries. The Council recommended revising boundaries of some existing EFHCAs and establishing new EFHCAs in some areas. The new suite of EFHCAs are anticipated to minimize the adverse effects of fishing to groundfish EFH. The Council also recommended reopening the trawl rockfish conservation area (trawl RCA) off Oregon and California. These historically important fishing areas have been closed since 2002 to rebuild overfished groundfish species during a period when the fishery was primarily managed using trip limits. In recent years, NMFS has declared as rebuilt the overfished groundfish stocks most commonly found at depths within the trawl RCA. In addition, the trawl rationalization program has increased incentives for fishermen to use precaution in areas where they may encounter rebuilding stocks and to generally reduce discards. Reopening the trawl RCA off Oregon and California is anticipated to increase the flexibility to vessels fishing with bottom trawl gear so they can harvest a higher proportion of their groundfish quotas. The combination of new and revised EFHCAs and the reopening of the trawl RCA is anticipated to minimize adverse impacts to groundfish EFH from the effects of fishing, while providing participants in the trawl rationalization program additional flexibility for efficient and sustainable harvest of groundfish species with bottom trawl gear.
The Council also considered new information regarding the deep-water habitats, including the presence of deep-sea corals in waters greater than 3,500 meters. While little to no fishing occurs with gears that are designed to make contact with the bottom in this area, permanent damage to these habitats could occur from future prospective fishing with bottom contact gear. These depths are deeper than designated groundfish EFH. Therefore, Amendment 28 would use the discretionary authority provisions in the Magnuson-Stevens Act to close the EEZ seaward of
The Council also recommended changes to the FMP that do not have corresponding regulation changes or on the water effects. The Council recommended revising the FMP by updating the description of fishing effects on designated EFH from fisheries that are not managed under the Magnuson-Stevens Act, the purpose of the periodic EFH review and the summaries for research and data needs. The Council also recommended revising the FMP by updating the groundfish life history and the text description of designated EFH, the effects of fishing and non-fishing activities on designated EFH, and latitude and longitude coordinates and maps of EFHCAs. The Council also recommended archiving portions of EFH-related appendices that no longer reflected the best scientific information available.
NMFS welcomes comments on the proposed FMP amendment through the end of the comment period. A proposed rule to implement Amendment 28 has been submitted for Secretarial review and approval. NMFS expects to publish and request public review and comment on proposed regulations to implement Amendment 28 in the near future. For public comments on the proposed rule to be considered in the approval or disapproval decision on Amendment 28, those comments must be received by the end of the comment period on the amendment. All comments received by the end of the comment period for the amendment, whether specifically directed to the amendment or the proposed rule, will be considered in the approval/disapproval decision.
16 U.S.C. 1801
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to collect information on the FSIS Form PY-200 “Egg Products Inspection Certificate.” FSIS is seeking approval for the FSIS Form PY-200, so that industry personnel can assist FSIS with its completion. This is a new information collection with an estimated annual burden of 96,360 hours.
Submit comments on or before August 12, 2019.
FSIS invites interested persons to submit comments on this
•
•
•
Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
FSIS intends to collect information on the FSIS Form PY-200 “Egg Products Inspection Certificate.” FSIS is seeking approval for the FSIS Form PY-200 so that industry personnel can assist FSIS with its completion (9 CFR 590.220). This is a new information collection with an estimated burden of 96,360 hours.
The FSIS Form PY-200 “Egg Products Inspection Certificate” is a USDA-FSIS serially numbered official form that has multiple uses within the egg products inspection program. IPP assigned to an official egg products plant issue the FSIS Form PY-200 for various reasons. The form is used to record inspection results, such as information indicating that IPP have examined the type (
FSIS has made the following estimates on the basis of an information collection assessment.
Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS will also announce and provide a link to this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Done in Washington, DC.
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to collect information from applicants that want to obtain specimens of condemned or other inedible materials from official establishments. This is a new information collection with an estimated burden of 274 hours.
Submit comments on or before August 12, 2019.
FSIS invites interested persons to submit comments on this
•
•
•
Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
FSIS requires any person desiring specimens of condemned or other inedible materials, including embryos and specimens of animal parasites, to file a written application on the FSIS Form 6700-2, “Application and Permit to Obtain Specimens from Official Establishments,” as provided in 9 CFR 314.9(a). The applicant must indicate the purpose for the specimens and arrange with and receive permission from the official establishment to obtain the specimens.
Under the regulations, official establishments may release specimens for educational, research or other nonfood purposes under the permit issued by the inspector in charge. The applicant agrees that the collection and handling of the specimens will be at such time and place and in such a manner as not to interfere with inspection or to cause any objectionable condition.
FSIS has made the following estimates on the basis of an information collection assessment.
Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS will also announce and provide a link to this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Done in Washington, DC.
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to renew the approved information collection regarding the accredited laboratory contact update form. The approval for this information collection will expire on November 30, 2019. FSIS is making no changes to the existing information collection.
Submit comments on or before August 12, 2019.
FSIS invites interested persons to submit comments on this
•
•
•
Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
In addition, the Food, Agriculture, Conservation, and Trade Act of 1990, as amended, (7 U.S.C. 138-138i) provides authority for the accreditation of non-Federal laboratories. Under these provisions, FSIS accredits non-Federal laboratories as eligible to perform analysis on official regulatory meat and poultry samples.
Non-Federal laboratories that are part of the FSIS Accredited Laboratory Program complete the FSIS Accredited Laboratory Program Annual Contact Update Form annually. FSIS the form to maintain corporate information concerning the laboratories and necessary contact information for responsibly connected personnel at the laboratories (see 9 CFR 439.20(e) and 9 CFR 439.1(w)). The completed FSIS Accredited Laboratory Program Annual Contact Update Form also informs the Agency if a laboratory, or responsibly connected person or entity, has been charged, indicted, or convicted of any crime listed in 9 CFR 439.52. If a laboratory or a responsibly connected person or entity has been charged or indicted of such a crime, FSIS will suspend the laboratory from the Accredited Laboratory Program (9 CFR 439.52). If a laboratory or a responsibly connected person or entity has been convicted of such a crime, FSIS will revoke the laboratory's accreditation (9 CFR 439.53).
The approval for this information collection will expire on November 30, 2019. FSIS is making no changes to the existing information collection. FSIS has made the following estimates on the basis of an information collection assessment.
Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS will also announce and provide a link to this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Done in Washington, DC.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Idaho Advisory Committee (Committee) to the Commission will be held at 12 p.m. (Mountain Time) on Tuesday, June 25, 2019. The purpose of the meeting is to discuss the Committee's ongoing project on Native American voting rights in Idaho.
The meeting will be held on Tuesday, June 25, 2019, at 12 p.m. Mountain Time.
Alejandro Ventura at
This meeting is available to the public
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Alejandro Ventura at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Please click on the “Committee Details” tab. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website,
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the New Mexico Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Mountain Time) Tuesday, June 18, 2019. The purpose of the meeting is for the Committee to discuss its study of wage issues in the state.
The meeting will be held on Tuesday, June 18, 2019, at 1:00 p.m. Mountain Time.
Alejandro Ventura at
This meeting is available to the public through the following toll-free call-in number: 877-260-1479, conference ID number: 1983705. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Alejandro Ventura at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Please click on “Committee Meetings” tab. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website,
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a public meeting on Tuesday, June 18, 2019; 1:30 p.m. to continue discussion of the Legal Financial Obligation (LFO) report.
The meeting will be held on Tuesday, June 18, 2019; 1:30 p.m. EDT.
Jeff Hinton, DFO, at 312-353-8311 or
Teleconference 877-260-1479, Conference ID: 5777519.
Members of the public are invited to come in and listen to the discussion.
Bureau of Economic Analysis, Department of Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before August 12, 2019.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230, or via email at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Jessica Hanson, Chief, Direct Transactions and Positions Branch (BE-49Q), Bureau of Economic Analysis, U.S. Department of Commerce, 4600 Silver Hill Rd., Washington, DC 20233; or via email at
The Survey of New Foreign Direct Investment in the United States (BE-13) collects information on the acquisition and establishment of U.S. business enterprises by foreign investors and on expansions by existing U.S. affiliates of foreign companies. Foreign direct investment is defined as the ownership or control by one foreign person (foreign parent) of 10 percent or more of the voting securities of an incorporated U.S. business enterprise, or an equivalent interest of an unincorporated U.S. business enterprise, including a branch. The data collected through the survey are used to measure the amount of new foreign direct investment in the United States, assess the impact on the U.S. economy, and ensure complete coverage of BEA's other foreign direct investment statistics.
The Bureau of Economic Analysis (BEA) does not propose any changes to the survey.
Notifications will be mailed to respondents as BEA becomes aware of a potentially reportable investment or when annual cost updates are needed. A business enterprise that meets the reporting requirements of the survey is required to report whether or not it is contacted by BEA. A business enterprise that is contacted by BEA and does not meet the reporting requirements is required to respond to indicate that it does not meet the requirements. The survey is due 45 days after (1) an acquisition is completed, (2) a new U.S. business enterprise is established, (3) an expansion is begun, (4) a cost update is requested by BEA, or (5) a U.S. business enterprise that does not meet the filing requirements for the survey receives a notification letter from BEA.
BEA offers electronic filing through its eFile system for use in reporting on the BE-13 survey forms. In addition, BEA posts all its survey forms and reporting instructions on its website (
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The list of commercially unavailable fabrics, yarns, and fibers may be changed pursuant to the commercial availability provision in Chapter 3, Article 3.3, Paragraphs 5-7 of the Agreement. Section 203(o) of the Act implements the commercial availability provision of the Agreement. Under this provision, interested entities from Peru or the United States have the right to request that a specific fabric, yarn, or fiber be added to, or removed from, the list of commercially unavailable fabrics, yarns, and fibers in Annex 3-B.
Section 203(o) of the Act provides that the President may modify the list of fabrics, yarns, and fibers in Annex 3-B by determining whether additional fabrics, yarns, or fibers are not available in commercial quantities in a timely manner in the United States or Peru, and that the President will issue procedures governing the submission of requests and providing an opportunity for interested entities to submit comments. The President delegated the responsibility for publishing the procedures and administering commercial availability requests to CITA, which issues procedures and acts on requests through the U.S. Department of Commerce, Office of Textiles and Apparel (OTEXA) (
The intent of the Commercial Availability Procedures is to foster the use of U.S. and regional products by implementing procedures that allow products to be placed on or removed from a product list, on a timely basis, and in a manner that is consistent with normal business practice. The procedures are intended to facilitate the transmission of requests; allow the market to indicate the availability of the supply of products that are the subject of requests; make available promptly, to interested entities and the public, information regarding the requests for products and offers received for those products; ensure wide participation by interested entities and parties; allow for careful review and consideration of information provided to substantiate requests and responses; and provide timely public dissemination of information used by CITA in making commercial availability determinations.
CITA must collect certain information about fabric, yarn, or fiber technical specifications and the production capabilities of Peruvian and U.S. textile producers to determine whether certain fabrics, yarns, or fibers are available in commercial quantities in a timely manner in the United States or Peru, subject to Section 203(o) of the Act.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that certain hardwood plywood with face and back veneers of radiata and/or agathis pine that: (1) Has a Toxic Substances Control Act (TSCA) or California Air Resources Board (CARB) label certifying that it is compliant with TSCA/CARB requirements; and (2) is made with a resin, the majority of which is comprised of one or more of three product types—urea formaldehyde, polyvinyl acetate, and/or soy—(inquiry merchandise), exported from the People's Republic of China (China), is circumventing the antidumping (AD) and countervailing duty (CVD) orders on certain hardwood plywood products from China.
Applicable June 11, 2019.
Rachel Greenberg, or Hannah Falvey AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0652, or (202) 482-4889 respectively.
On September 21, 2018, Commerce published in the
The products covered by the
This anti-circumvention inquiry covers certain plywood products with face and back veneers of radiata and/or agathis pine that: (1) TSCA or CARB label certifying that it is compliant with TSCA/CARB requirements; and (2) is made with a resin, the majority of which is comprised of one or more of the following three product types: Urea formaldehyde, polyvinyl acetate, and/or soy exported from China. This preliminary ruling applies to all shipments of inquiry merchandise on or after the date of the initiation of this inquiry. Importers and exporters of plywood from China with both outer veneers made of a softwood species of wood (softwood plywood products), must certify that the softwood plywood products do not meet all three of the following criteria: (1) Have both outer veneers of radiata and/or agathis pine; (2) are made with a resin, the majority of which is comprised of urea formaldehyde, polyvinyl acetate, and/or soy; and (3) have a TSCA or CARB label certifying that they are compliant with TSCA/CARB requirements, as provided for in the certifications in the appendices to this
Commerce is conducting this anti-circumvention inquiry in accordance with section 781(d) of the Act. For a full description of the methodology underlying Commerce's preliminary determination,
As detailed in the Preliminary Decision Memorandum, we preliminarily determine that the inquiry merchandise exported from China is circumventing the
In accordance with 19 CFR 351.225(l)(2), Commerce will direct CBP to suspend liquidation and to require a cash deposit of estimated duties on unliquidated entries of inquiry merchandise that were entered, or withdrawn from warehouse, for consumption on or after September 18, 2018, the date of initiation of the anti-circumvention inquiry.
The suspension of liquidation instructions will remain in effect until further notice. Commerce will instruct CBP to require AD cash deposits equal to the China-wide rate of 182.90 percent and CVD cash deposits equal to the rate established for the China all-others rate of 22.98 percent, unless the importer/exporter can certify to CBP that the Chinese-origin inquiry merchandise was supplied by a Chinese manufacturer with a company-specific separate rate. In that instance, the cash deposit rate will be the rate of the Chinese inquiry merchandise manufacturer that has its own rate.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last final verification report is issued in this anti-circumvention inquiry, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined.
Commerce, consistent with section 781(e) of the Act, has notified the International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this anti-circumvention inquiry within the
This determination is issued and published in accordance with section 781(d) of the Act and 19 CFR 351.225(j).
If an importer imports plywood from China with outer veneers both made of softwood plywood, and claims that its softwood plywood products produced in China do not meet all three of the following criteria: (1) Have both outer veneers of radiata and/or agathis pine; (2) are made with a resin, the majority of which is comprised of urea formaldehyde, polyvinyl acetate, and/or soy; and (3) have a Toxic Substances Control Act (TSCA) or California Air Resources Board (CARB) label certifying that they are compliant with TSCA/CARB requirements, then the importer is required to complete and maintain the importer certification attached hereto as Appendix III.
The importer and exporter are required to maintain the exporter certification attached hereto as Appendix IV. The importer certification must be completed, signed, and dated at the time of the entry of the plywood product. The exporter certification must be completed, signed, and dated at the time of shipment of the relevant entries. For shipments and/or entries on or after June 4, 2019, but before the publication of this notice in the
I hereby certify that:
• My name is {INSERT COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY};
• This certification pertains to {INSERT ENTRY NUMBER(S), ENTRY LINE NUMBER(S), AND PRODUCT CODE(S) REFERENCED ON ENTRY SUMMARY};
• I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of the plywood with both outer veneers made of a softwood species of wood (softwood plywood products) produced in the People's Republic of China (China) that entered under entry number(s) {INSERT ENTRY NUMBER(S)} and are covered by this certification. “Direct personal knowledge” for purposes of this certification refers to facts in records maintained by the importing company in the normal course of its business. The importer should have “direct personal knowledge” of the importation of the product (
• I have personal knowledge of the facts regarding the production of the imported softwood plywood products covered by this certification. “Personal knowledge” for purposes of this certification includes facts obtained from another party (
• The softwood plywood products produced in China that are covered by this certification are not subject to the orders on certain hardwood plywood products from China because they do not meet all three of the following criteria: (1) Have both outer veneers of radiata and/or agathis pine; (2) are made with a resin, the majority of which is comprised of urea formaldehyde, polyvinyl acetate, and/or soy; and (3) have a Toxic Substances Control Act (TSCA) or California Air Resources Board (CARB) label certifying that they are compliant with TSCA/CARB requirements;
• I understand that {INSERT IMPORTING COMPANY NAME} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
• I understand that {INSERT IMPORTING COMPANY NAME} is required to provide this certification and supporting records, upon request, to U.S. Customs and Border Protection (CBP) and/or the Department of Commerce (Commerce);
• I understand that {INSERT IMPORTING COMPANY NAME} is required to maintain a copy of the Exporter's Certification for the later of (1) a period of five years from the date of entry or (2) a period of three years after the conclusion of any litigation in United States courts regarding such entries;
• I understand that {INSERT IMPORTING COMPANY NAME} is required to maintain and provide a copy of the Exporter's Certification and supporting records, upon request, to CBP and/or Commerce;
• I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
• I understand that failure to maintain the required certification and/or failure to substantiate the claims made herein will result in:
○ Suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met, and
○ the requirement that the importer post applicable antidumping duty (AD) and/or countervailing duty (CVD) cash deposits (as appropriate) equal to the rates determined by Commerce;
• I understand that agents of the importer, such as brokers, are not permitted to make this certification;
• This certification was completed at the time of filing the entry summary for the relevant importation; and
• I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
I hereby certify that:
• My name is {INSERT COMPANY OFFICIAL'S NAME HERE} and I am an official of {INSERT NAME OF EXPORTING COMPANY};
• I have direct personal knowledge of the facts regarding the production and exportation of the plywood with both outer veneers made of a softwood species of wood (softwood plywood products) identified below;
• The softwood plywood products produced in China that are covered by this certification are not subject to the orders on certain hardwood plywood products from China because they do not meet all three of the following criteria: (1) Have both outer veneers of radiata and/or agathis pine; (2) are made with a resin, the majority of which is comprised of urea formaldehyde, polyvinyl acetate, and/or soy; and (3) have a Toxic Substances Control Act (TSCA) or California Air Resources Board (CARB) label certifying that they are compliant with TSCA/CARB requirements;
• I understand that {INSERT NAME OF EXPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification for the later of (1) a period of five years from the date of entry or (2) a period of three years after the conclusion of any litigation in the United States courts regarding such entries;
• I understand that {INSERT NAME OF EXPORTING COMPANY} must provide this Exporter Certification to the U.S. importer at the time of shipment;
• I understand that {INSERT NAME OF EXPORTING COMPANY} is required to provide a copy of this certification and supporting records, upon request, to U.S. Customs and Border Protection (CBP) and/or the Department of Commerce (Commerce);
• I understand that the claims made herein, and the substantiating documentation are subject to verification by CBP and/or Commerce;
• I understand that failure to maintain the required certification and/or failure to substantiate the claims made herein will result in:
○ Suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met and
○ the requirement that the importer post applicable antidumping duty (AD) and countervailing duty (CVD) cash deposits equal to the rates as determined by Commerce;
• This certification was completed at or prior to the time of shipment; and
• I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on sodium nitrite from the People's Republic of China (China) would be likely to lead to the continuation or recurrence of a countervailable subsidy at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 11, 2019.
Leo Ayala or Jacqueline Arrowsmith, Office VII, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3945 or (202) 482-5255, respectively.
On August 27, 2008, Commerce published the CVD order on sodium nitrite from China.
Commerce did not receive a response from the Government of the People's Republic of China or any respondent interested parties. On March 20, 2019, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from respondent interested parties.
The merchandise covered by this order is sodium nitrite in any form, at any purity level. A full description of the scope of the
All issues raised in this sunset review are addressed in the Issues and Decision Memorandum. The issues discussed include the likelihood of continuation or recurrence of a countervailable subsidy and the net countervailable subsidy rate likely to prevail if the
Pursuant to sections 752(b)(1) and (3) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
Commerce is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order certain hot-rolled carbon steel flat products from Thailand would be likely to lead to the continuation or recurrence of net countervailable subsidies at the rates in the “Final Results of Review” section of this notice.
Applicable June 11, 2019.
Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-5255.
On December 3, 2001, Commerce published the
Commerce received a complete substantive response to the notice of initiation from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The merchandise subject to this
All issues raised in this sunset review are addressed in the Issues and Decision Memorandum. The issues discussed in the Issues and Decision Memorandum include the likelihood of continuation or recurrence of a countervailable subsidy and the net countervailable subsidy likely to prevail if the
Pursuant to sections 752(b)(1) and (3) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
Commerce is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of these expedited sunset reviews, Commerce finds that revocation of the antidumping duty orders would be likely to lead to the continuation or recurrence of dumping at the levels indicated in the “Final Results of Review” section of this notice.
Applicable June 11, 2019.
Ian Hamilton AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4798.
On February 5, 2019, Commerce published the notice of initiation of the second sunset review of the antidumping duty orders on sodium nitrite from Germany and the People's Republic of China (China)
On March 7, 2019, Commerce received adequate substantive responses to the notice of initiation from
On March 20, 2019, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from respondent interested parties.
The merchandise subject to these orders is sodium nitrite in any form, at any purity level. In addition, the sodium nitrite covered by these orders may or may not contain an anti-caking agent. Examples of names commonly used to reference sodium nitrite are nitrous acid, sodium salt, anti-rust, diazotizing salts, erinitrit, and filmerine. The chemical composition of sodium nitrite is NaNO
While the HTSUS subheading, CAS registry number, and CAS name are provided for convenience and customs purposes, the written description of the scope of these orders is dispositive.
All issues raised in these sunset reviews are addressed in the Issues and Decision Memorandum,
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the antidumping duty orders on sodium nitrite from Germany and China would be likely to lead to the continuation or recurrence of dumping at weighted-average dumping margins up to 237.00 percent for Germany and 190.74 percent for China.
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing the final results and this notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that revocation of the antidumping duty order on persulfates from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping, at the level indicated in the “Final Results of Sunset Review” section of this notice,
Applicable June 11, 2019.
Thomas Hanna, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0835.
On July 7, 1997, Commerce published in the
The products covered by the order are persulfates, including ammonium, potassium, and sodium persulfates. The chemical formulas for these persulfates are, respectively, (NH
A complete discussion of all issues raised in this sunset review, specifically the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the
Pursuant to sections 751(c)(1), 752(c)(1) and (3) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing the results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty order on non-malleable cast iron pipe fittings (NMPF) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the level identified in the “Final Results of Review” section of this notice.
Applicable June 5, 2019.
Ariela Garvett or Maliha Khan, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3609 or (202) 482-0895, respectively.
On April 7, 2003, the Department of Commerce (Commerce) published the notice of the antidumping duty order on NMPF from China.
The products covered by the
Fittings that are made out of ductile iron that have the same physical characteristics as the gray or cast iron fittings subject to the scope above or which have the same physical characteristics and are produced to ASME B.16.3, ASME B.16.4, or ASTM A-395 specifications, threaded to ASME B1.20.1 specifications and UL certified, regardless of metallurgical differences between gray and ductile iron, are also included in the scope of the
Imports of covered merchandise are classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers 7307.11.00.30, 7307.11.00.60, 7307.19.30.60 and 7307.19.30.85. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the
A complete discussion of all issues raised in this review, including the likelihood of continuation or recurrence of dumping in the event of revocation of the
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, 19 CFR 351.218, and 19 CFR 351.221(c)(5)(ii).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this expedited sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty order on certain laminated woven sacks from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the level indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 11, 2019.
Genevieve Coen, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3251.
On August 7, 2008, Commerce published the
On March 7, 2019, we received a complete substantive response from domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The merchandise subject to the
All issues raised in this review, including the likelihood of continuation or recurrence of dumping in the event of revocation and the magnitude of the margins of dumping likely to prevail if the
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, we determine that revocation of the antidumping duty
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on laminated woven sacks from the People's Republic of China (China) would be likely to lead to the continuation or recurrence of net countervailable subsidies at the rates in the “Final Results of Review” section of this notice.
Applicable June 11, 2019.
Thomas Dunne or Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-2328 or (202) 482-5255, respectively.
On August 7, 2008, Commerce published the
Commerce received a complete substantive response to the notice of initiation from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The merchandise covered by the
All issues raised in this sunset review are addressed in the Issues and Decision Memorandum. The issues discussed in the Issues and Decision Memorandum include the likelihood of continuation or recurrence of a countervailable subsidy and the net countervailable subsidy likely to prevail if the
Pursuant to sections 752(b)(1) and (3) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
Commerce is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this expedited sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty order on steel wire garment hangers (hangers) from the People's Republic of China (China) would be likely to lead to the continuation or recurrence of dumping at the level indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 11, 2019.
Genevieve Coen, AD/CVD Operations, Office V, Enforcement and Compliance,
On October 6, 2008, Commerce published the
On February 28, 2019, we received a complete substantive response from the domestic interested party within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The merchandise subject to the
All issues raised in this review, including the likelihood of continuation or recurrence of dumping in the event of revocation and the magnitude of the margins of dumping likely to prevail if the
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, we determine that revocation of the antidumping duty
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
International Trade Administration, U.S. Department of Commerce.
Notice of an open meeting.
The U.S. Department of Commerce Trade Finance Advisory Council (TFAC or Council) will hold a meeting via teleconference on Thursday, June 20, 2019. The meeting is open to the public with registration instructions provided below.
Thursday, June 20, 2019, from approximately 1:00 p.m. to 3:00 p.m. Eastern Time (ET). The deadline for members of the public to register, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5:00 p.m. ET on Monday, June 17, 2019. Registration, comments, and any auxiliary aid requests should be submitted via email to
The meeting will be held by conference call. The call-in number and passcode will be provided by email to registrants. Requests to register (including for auxiliary aids) and any written comments should be submitted via email to
Ericka Ukrow, Designated Federal Officer, Office of Finance and Insurance Industries (OFII), International Trade Administration, U.S. Department of Commerce at (202) 482-0405; email:
The TFAC was established on August 11, 2016, pursuant to discretionary authority and in accordance with the Federal Advisory Committee Act, as amended, 5 U.S.C. App., and re-
On Thursday, June 20, 2019, the TFAC will hold the second meeting of its 2018-2020 charter term. During the meeting, TFAC subcommittee members will present initial proposals for potential recommendations on policies and programs that can increase awareness of, and expand access to, export financing resources for U.S. exporters for discussion with the broader TFAC and officials from the Department of Commerce and other agencies. Meeting minutes will be available within 90 days of the meeting upon request or on the TFAC's website at
The meeting will be open to the public and there will be limited time permitted for public comments.
In order to be considered at the meeting, comments from members of the public must be submitted by the deadline identified under the
Members of the public may submit written comments concerning TFAC affairs at any time before or after a meeting. Comments may be submitted to Ericka Ukrow, at the contact information indicated above. All comments and statements received, including attachments and other supporting materials, are part of the public record and subject to public disclosure.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments
The Regional Administrator, West Coast Region, NMFS, has made a preliminary determination that an application for an Exempted Fishing Permit warrants further consideration. The application, submitted by the West Coast Pelagic Conservation Group (a non-profit industry group), requests an exemption from the expected prohibition of directed fishing for Pacific sardine for the 2019-2020 fishing year to collect Pacific sardine as part of an industry-based scientific survey. NMFS requests public comment on the application.
Comments must be received by June 26, 2019.
You may submit comments on this document, identified by NOAA-NMFS-2019-0055, by any of the following methods:
•
•
•
Lynn Massey, West Coast Region, NMFS, (562) 436-2462,
On May 28, 2019, NMFS published a proposed rule (84 FR 24459) to implement Pacific sardine harvest specifications for the 2019-2020 fishing year off the U.S. West Coast. This proposed rule included a 4,000 metric ton (mt) annual catch target (ACT) and a prohibition on directed commercial fishing for Pacific sardine off the coasts of Washington, Oregon, and California (except for small directed catch and catch of live bait). At the April 2019 Pacific Fishery Management Council (Council) meeting, the Council voted in support of the West Coast Pelagic Conservation Group's (WCPCG) EFP application and one other application that is being processed on a separate track. The WCPCG's application requests an exemption from the prohibition to directly harvest Pacific sardine. The proposed 2019-2020 Pacific sardine harvest specifications take into account the potential for up to 405 mt (the combined total of the two EFP proposals the Council reviewed) of the ACT to be harvested under EFPs.
The WCPCG EFP application requests a permit to directly harvest 10 mt of CPS, of which the applicant estimates no more than 5 mt will be Pacific sardine. The purpose of the EFP is to collect biological samples in areas inshore of the 2019 NMFS Southwest Fisheries Science Center acoustic trawl survey to better assess species composition and CPS distribution and abundance. An EFP is necessary to conduct this collection because the proposed 2019-2020 harvest specifications would prohibit most directed fishing for Pacific sardine. The collections under the EFP would take place between approximately June 25, 2019, and August 31, 2019. If NMFS
16 U.S.C. 1801
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The survey will also investigate the reasons that prevented observers from reporting these violations. The results of the survey will provide the Office of Law Enforcement a better understanding of how often observers are victimized, which will enable them to reallocate resources as needed, conduct more training for observers to ensure they know how to report, conduct training to ensure people understand what constitutes a victim crime, and to increase awareness of potential victimizations. Additionally, the survey results will help law enforcement understand the barriers to disclosure, so enforcement may begin to address these impediments so they no longer prevent observers from disclosure.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Corporation for National and Community Service (CNCS).
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1) By mail sent to: Corporation for National and Community Service, Attention: Nahid Jarrett, 250 E Street SW, Washington, DC 20525.
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may use our web chat for alternative communication
Comments submitted in response to this notice may be made available to the public through
Nahid Jarrett, 202-606-6753, or by email at
The
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection on
Corporation for National and Community Service (CNCS).
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may use our web chat for alternative communication
Comments submitted in response to this notice may be made available to the public through
Nahid Jarrett, 202-606-6753, or by email at
The National Service Trust AmeriCorps Forbearance Request for National Service Form or its electronic versions, is used to certify that AmeriCorps members are eligible for forbearance based on their enrollment in a national service position. AmeriCorps members use the form, or its electronic equivalents, to request forbearance. This information collection is not required to be considered for obtaining grant funding support. The currently approved information collection is due to expire on August 31, 2019.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection on
Corporation for National and Community Service (CNCS).
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may use our web chat for alternative communication
Comments submitted in response to this notice may be made available to the public through
Nahid Jarrett, 202-606-6753, or by email at
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the
United States Army Corps of Engineers, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by August 12, 2019.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Waterborne Commerce Statistics Center, P.O. Box 60267, New Orleans, Louisiana 70160, John Dubberley or call the Waterborne Statistics Center at (504) 862-1404.
The aggregate data collected under these programs are published in the annual publications, Waterborne Commerce of the United States, Parts 1-5, Lock Performance Monitoring System Quarterly Reports, and Waterborne Transportation Lines of the United States. Each data base and publication provide essential information for an understanding of the utilization of our Nation's navigation systems and the fleet using these systems. The data bases provide essential information to those with the responsibilities over the physical system or to those involved in shipping or moving commodities on the Nation's waterways.” [River and Harbor Act of September 22, 1922 (42 Stat. 1043)].
The end result of using both the 3925 series and ENG Form 3926, despite collecting very similar data, is to ensure WCSC is able to paint a complete picture of vessel movements and cargo carried on U.S. waterways. Each set of data produced from the forms allows WCSC to ensure accuracy and completeness. The data are used to annually publish Waterborne Commerce of the United States (WCUS) Ports and Waterways which presents detailed data on the movements of vessels and commodities at the ports and harbors and on the waterways and canals of the United States and its territories. It also provides statistics on the foreign and domestic waterborne commerce moved through the U.S. waters. Congress receives this annual report, and the data contained therein are used in cost-benefit analyses for new projects, rehabilitation projects, and operations and maintenance of existing projects. It is also used by other Federal agencies involved in transportation and security. Researchers and private organizations also use the data regularly to help decide on which locales are best models for their studies/needs.
Department of the Navy, DoD.
Notice.
The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.
Requests for copies of the patents cited should be directed to Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001.
Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, Email
The following patents are available for licensing: Patent No. 10,279,519 (Navy Case No. 103209): MOLD ASSEMBLY AND METHOD OF MOLDING A COMPONENT//Patent No. 10,288,497 (Navy Case No. 200266): APPARATUS FOR DESTRUCTIVE EVENT TESTING OF CHEMICAL ENERGY SYSTEMS USING ADAPTIVE HEAT FLOW TESTING SYSTEMS AND RELATED METHODS//Patent No. 10,288,572 (Navy Case No. 200397): APPARATUS FOR DESTRUCTIVE EVENT TESTING OF CHEMICAL ENERGY SYSTEMS USING HIGHLY PORTABLE AND EASE OF ACCESS ADAPTIVE HEAT FLOW TESTING SYSTEMS INCLUDING REPLACEABLE AND THERMALLY ISOLATED MODULAR THERMAL SECTIONS EACH CAPABLE OF INDEPENDENT MEASUREMENT OF A TEST ARTICLE WITH IMPROVED EASE OF TEST ARTICLE INSERTION AND REMOVAL AND RELATED METHODS//and Patent No. 10,305,241 (Navy Case No. 200413): METHOD OF MANUFACTURING A HAND TOOL FOR COUPLING TOGETHER FIRST AND SECOND CABLE SECTIONS.
35 U.S.C. 207, 37 CFR part 404.
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for new individual development awards for fiscal year (FY) 2019 for the Promoting Postbaccalaureate Opportunities for Hispanic Americans (PPOHA) Program, Catalog of Federal Domestic Assistance (CFDA) number 84.031M. This notice relates to the approved information collection under OMB control number 1894-0006.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Dr. Maria E. Carrington, U.S. Department of Education, 400 Maryland Avenue SW, Room 260-10, Washington, DC 20202. Telephone: (202) 453-7339. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
For many students that do receive a bachelor's degree, enrolling and persisting through a graduate program can be daunting, especially for first-generation students. The PPOHA program supports institutions that seek to develop, enhance, and promote postbaccalaureate opportunities for Hispanic students.
These priorities are:
Projects that propose collaboration with other institutions of higher education to expand postbaccalaureate certificate and postbaccalaureate degree offerings.
Projects that are designed to support instruction in personal financial literacy, knowledge of markets and economics, knowledge of higher education financing and repayment (
This priority is:
Under this priority, we are particularly interested in projects that are designed to establish, improve, or expand PSM degree programs, which combine traditional academic training with specialized knowledge and skills that: (a) Closely align with the expectations and needs of business and industry and (b) prepare students for direct entry into a variety of science, technology, engineering, and mathematics (STEM) career options in business and industry, Federal government, or non-profit organizations.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent fiscal years from the list of unfunded applications from this competition.
1.
Applicants also must meet the following criteria from the Final Requirements:
(a) Have an enrollment of needy students, as defined in section 502(b) of the HEA (20 U.S.C. 1101a(b)) (cross-referenced in section 502(a)(2)(A)(i) of the HEA; 20 U.S.C. 1101a(a)(2)(A)(i));
(b) Have, except as provided in section 522(b) of the HEA (20 U.S.C. 1103a(b)), average educational and general expenditures that are low, per full-time equivalent (FTE) undergraduate student, in comparison with the average educational and general expenditures per FTE undergraduate student of institutions that offer similar instruction (section 502(a)(2)(A)(ii) of the HEA; 20 U.S.C. 1101a(a)(2)(A)(ii));
(c) Be accredited by a nationally recognized accrediting agency or association that the Secretary has determined to be a reliable authority as to the quality of education or training offered, or making reasonable progress toward accreditation, according to such an agency or association (section 502(a)(2)(A)(iv) of the HEA; 20 U.S.C. 1101a(a)(2)(A)(iv));
(d) Be legally authorized to provide, and provide within the State, an educational program for which the institution awards a bachelor's degree (section 502(a)(2)(A)(iii) of the HEA; 20 U.S.C. 1101a(a)(2)(A)(iii)); and
(e) Have an enrollment of undergraduate FTE students that is at least 25 percent Hispanic students at the end of the award year immediately preceding the date of application (section 502(a)(5)(B) of the HEA; 20 U.S.C. 1101a(a)(5)(B)).
For purposes of this competition, the data that we will use to determine percent enrollment for school year is 2017-2018.
2. a.
b.
3.
4.
(a)
(b)
1.
2.
3.
4.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative. Titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs, are excluded.
• Use a font that is either 12 point or larger, and no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract and the bibliography. However, the recommended page limit does apply to all of the application narrative.
1.
(a)
(i) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project. (up to 2 points)
(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses. (up to 3 points)
(b)
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (up to 5 points)
(ii) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (up to 5 points)
(iii) The extent to which the proposed project demonstrates a rationale (as defined in this notice) (up to 5 points)
(c)
(i) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services. (up to 10 points)
(ii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practice. (up to 5 points)
(iii) The extent to which the design for implementing and evaluating the proposed project will result in information to guide possible replication of project activities or strategies, including information about the effectiveness of the approach or strategies employed by the project. (up to 5 points)
(d)
The Secretary considers the significance of the proposed project. In determining the significance of the proposed project, the Secretary considers the extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.
(e)
(i) The extent to which the budget is adequate to support the proposed project. (up to 5 points)
(ii) The potential for the incorporation of project purposes, activities, or benefits into the ongoing program of the agency or organization at the end of Federal funding. (up to 10 points)
(f)
In addition, the Secretary considers the extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project. (up to 5 points)
(g)
(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (up to 10 points)
(ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project. (up to 10 points)
(h)
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (up to 5 points)
(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible. (up to 5 points)
(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes. (up to 5 points)
2.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
A panel of three non-Federal reviewers will review and score each application in accordance with the selection criteria in 34 CFR 75.210. A rank order funding slate will be made from this review and the competitive preference priority points. Awards will be made in rank order according to the average score received from the peer review.
In the event there are two or more applications with the same final score, and there are insufficient funds to fully support each of these applications, the Department will use other information to select applications (as noted in 34 CFR 75.217). This information is included below. The Department will apply the following procedure to determine which application or applications will receive an award:
First Tiebreaker: The first tiebreaker will be the highest average score for the selection criterion “Quality of Project Services.” If a tie remains, the second tiebreaker will be utilized.
Second Tiebreaker: The second tiebreaker will be the highest average score for the selection criterion “Quality of Project Design.” If a tie remains, the third tiebreaker will be utilized.
Third Tiebreaker: The third tiebreaker will be the highest average score for the selection criterion “Quality of Project Evaluation.”
3.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
5.
(a) The percentage change, over the five-year grant period, of the number of full-time degree-seeking graduate and professional students enrolled at HSIs currently receiving an award under this program.
(b) The percentage change, over the five-year grant period, of the number of master's, doctoral, and first-professional degrees and postbaccalaureate certificates awarded at HSIs currently receiving an award under this program; and
(c) Cost per successful outcome: The Federal cost per master's, doctoral, and first-professional degree and postbaccalaureate certificate awarded at HSIs currently receiving an award under this program.
6.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before July 11, 2019.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Kashka Kubzdela, 202-245-7377 or email
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).
Request for information (RFI).
The U.S. Department of Energy (DOE) invites public comment on the Marine Sciences Laboratory Request for Information (RFI). This RFI is seeking feedback addressing the growing Research and Development (R&D) interest in the use of the Department of Energy's Pacific Northwest National Laboratory (PNNL) Marine Sciences Laboratory (MSL) facilities for renewable energy, maritime markets, and energy storage research, technology development and testing. This information will help DOE and PNNL prioritize resources and investments at the MSL.
Responses to the RFI must be received by no later than 5:00 p.m. (ET) on July 31, 2019.
Interested parties should submit comments electronically to
Questions may be addressed to
Pacific Northwest National Laboratory's (PNNL) Marine Sciences Laboratory (MSL), located in Washington State, is the U.S. Department of Energy's (DOE) only marine research facility. The laboratory helps the Nation achieve sustainable energy, a healthy environment, and robust security in coastal settings. The purpose of this request for information is to solicit feedback from industry, academia, other national laboratories, government agencies, and private entities regarding the use of this unique DOE marine laboratory as a research, development, testing, and validation venue supporting multiple DOE missions as they relate to the coastal and ocean environment.
Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email two well marked copies: One copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person that would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. The application is not ready for environmental analysis at this time.
k.
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
m.
Issue Notice of Application Tendered: June 2019.
Issue Notice of Application Acceptance and Soliciting Final Terms and Conditions: August 2019.
Commission issues EA: December 2019.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The environmental staff of the Federal Energy Regulatory Commission (Commission) along with other federal agency staff will meet with representatives of The Klamath Tribes to discuss the proposed Jordan Cove Energy Project. The meeting will be held at the location and time listed below:
Members of the public and intervenors in the referenced proceeding may attend and observe this meeting; however, participation will be limited to tribal representatives and federal agency staff. If tribal representatives choose to disclose information about a specific location which could create a risk or harm to an archeological site or Native American cultural resource, the public will be excused for that portion of the meeting. A summary of the meeting will be entered into the Commission's administrative record.
If you plan to attend this meeting, please contact Mr. John Peconom, Environmental Project Manager at (202) 502-6352 or
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will be present to receive comments on the draft Environmental Impact Statement for the Jordan Cove Energy Project as follows:
Please do not contact these venues directly with questions. Any questions regarding the public comment sessions should be directed to the FERC at: (866) 208-3372.
The public's review of a draft Environmental Impact Statement is an important part of the Commission's environmental review process. Although not required, the Commission is holding these public comment sessions, so that interested parties can provide their specific comments on the analyses and findings of the draft Environmental Impact Statement for the Jordan Cove Energy Project (draft EIS), which was issued on March 29, 2019. These comment sessions have been purposefully designed to efficiently and effectively allow for the greatest number of individuals to provide comments on the draft EIS.
Recognizing significant public interest for this project and in anticipation of a large turnout, FERC staff has chosen to allot more time for the public comment sessions than is typical. As described in the table above, the public comment sessions will be held between 1:00 and 8:00 p.m. You may arrive at any time after 1:00 p.m. Individuals arriving before 1:00 p.m. will not be permitted in the venue and should expect to wait.
There will be no formal presentations by Commission staff; however, staff will be present to answer general questions about the FERC and the environmental review process. Other federal agency representatives will be in attendance and available to answer questions about their respective roles and reviews.
If you wish to provide verbal comments, Commission staff will issue you a number upon arrival. Elected officials are exempted from the number process and will be afforded priority; otherwise, numbers will be called in the order issued. A waiting area will be provided, but please monitor the numbers being called, so that you do not miss your opportunity to comment. Once your number is called, you will be directed to a Commission staff team member and a court reporter who will transcribe your comments. Comments will be taken in a one-on-one setting. Due to the anticipated large turnout, a time limit of 3 minutes per commenter will be implemented. Depending on the number of people waiting, this time limit may be extended 1-2 minutes. To reduce potential wait times, there will be four court reporters at each session to receive comments. In order for the session to end on time, Commission staff will monitor and evaluate attendance, and may stop issuing numbers prior to 8:00 p.m.
All comments received will become part of the public record for these proceedings. Transcripts will be publicly available via FERC's eLibrary. It is important to note that electronic and written comments submitted to the Commission hold the same weight as verbal comments. Therefore, you do not need to attend a session in order for your comments to be considered.
As a reminder, electronic and written comments can be submitted in the following manner:
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket numbers (CP17-494-000 and CP17-495-00) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Protests, disruptions, and other distractions will be evaluated by Commission staff on a case-by-case basis. Should an activity significantly disrupt the session or result in an unsafe or unwelcoming environment, staff may choose to end the session for a set time or entirely. Please see appendix 1 for additional information on the session format and conduct.
Take notice that on June 3, 2019, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2018), Sunoco Pipeline L.P. (“SPLP”) filed a petition for a declaratory order seeking approval of the overall tariff rate structure and service terms, including priority service, for the Mariner East Expansion project, to transport ethane from southwestern Pennsylvania shale basins by using underutilized capacity on existing pipeline of Project Mariner East from Houston, Pennsylvania, to Delmont, Pennsylvania, and thence from Delmont to SPLP's affiliate's terminal in Marcus Hook, Pennsylvania, and Claymont, Delaware, by using a formerly mixed-use pipeline that will be converted to dedicated ethane service, all as more fully explained in the petition.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On May 9, 2019, UP Hydro, LLC (transferor), and Cataract Hydro, LLC (transferee) filed an application for the transfer of license of the Cataract Hydroelectric Project No. 10854. The project is located on the Escanaba River in Marquette County, Michigan.
The applicants seek Commission approval to transfer the license for the Cataract Hydroelectric Project from the transferor to the transferee.
For assistance, please contact FERC Online Support at
The environmental staff of the Federal Energy Regulatory Commission (Commission) along with other federal agency staff will meet with representatives of the Cow Creek Band of Umpqua Tribe of Indians to discuss the proposed Jordan Cove Energy Project. The meeting will be held at the location and time listed below:
Members of the public and intervenors in the referenced proceeding may attend and observe this meeting; however, participation will be limited to tribal representatives and agency staff. If tribal representatives choose to disclose information about a specific location which could create a risk or harm to an archeological site or Native American cultural resource, the public will be excused for that portion of the meeting. A summary of the meeting will be entered into the Commission's administrative record.
If you plan to attend this meeting, please contact Mr. John Peconom, Environmental Project Manager at (202) 502-6352 or
Office of Mission Support, Environmental Protection Agency.
Notice of a new system of records.
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Environmental Protection Agency (EPA) is providing notice of a new system of records, EPA ServiceNow (SNOW). SNOW is a Cloud-Based Software as a Service (SaaS) Information Technology Service Management platform used for agency incident and problem management.
Persons wishing to comment on this system of records notice must do so by July 11, 2019. New routine uses for this new system of records will be effective July 11, 2019.
Submit your comments, identified by Docket ID No. EPA-HQ-OEI-2018-0218, by one of the following methods:
•
•
•
•
•
Gloria Meriweather at
EPA ServiceNow is a FedRAMP approved (FedRAMP Package ID: F1305072116) Cloud Based Software as a Service (SaaS) incident and problem management solution that will be replacing the current EPA Remedy solution.
EPA ServiceNow (SNOW), EPA-78.
Unclassified.
Office of Environmental Information, Environmental Protection Agency, 1301 Constitution Ave., Washington, DC 20460.
SAIC Inc. 12010 Sunset Hills Road, Reston, VA 20190.
Willie J. Abney, Division Director of Desktop Support Services Division (DSSD), Office of Environmental Information, Office of Information Technology Operations, 1301 Constitution Ave., Washington, DC 20460 Email Address:
5 U.S.C. 301 “Departmental Regulations”, 8 U.S.C 1101, 1103, 1104, 1201, 1255, 1305, 1360; 44 U.S.C. 3101 “Records Management by Federal Agency Heads.”
This system will collect limited personally identifiable information (PII) from requestors (
• Managing service request tickets
• Retrieving incident information;
• Troubleshooting issues
• Managing IT assets
• Conveying outage information across the enterprise
All PII associated with the activities listed are only available and presented to internal (
Categories of individuals covered by this system include EPA employees, EPA contractors, non-EPA government personnel, state and local government personnel and/or private citizens (
Information collected in system are First and Last Name; Work/Business Address; Date; Work Number; Work Email Address; External Email Address (for non-EPA government personnel including state and local government personnel and/or private citizens); Employee LAN ID; Employee Number.
Information contained in this system is obtained from data provided directly from EPA employees and contractors via the EPA ServiceNow self-help portal, from Enterprise IT Service Desk personnel who have received technical support calls from requestors or pre-populated fields captured from EPA Active Directory.
The following new routine uses apply to this system because the use of the record is necessary for the efficient conduct of government. The routine uses are related to and compatible with the original purpose for which the information was collected. The last two routine uses are required under OMB M-17-12. Records in this system may be disclosed to the following entities:
•
Information may be disclosed to the appropriate Federal, State, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.
•
Information may be disclosed to any source from which additional information is requested (to the extent necessary to identify the individual, inform the source of the purpose of the request, and to identify the type of information requested,) when necessary to obtain information relevant to an agency decision concerning retention of an employee or other personnel action (other than hiring,) retention of a security clearance, the letting of a contract, or the issuance or retention of a grant, or other benefit.
•
Information may be disclosed to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of the individual.
•
Information may be disclosed to the Department of Justice, or in a proceeding before a court, adjudicative body, or other administrative body before which the Agency is authorized to appear, when:
✓ The Agency, or any component thereof;
✓ Any employee of the Agency in his or her official capacity;
✓ Any employee of the Agency in his or her individual capacity where the Department of Justice or the Agency have agreed to represent the employee; or
✓ The United States, if the Agency determines that litigation is likely to affect the Agency or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or the Agency is deemed by the Agency to be relevant and necessary to the litigation provided, however, that in each case it has been determined that the disclosure is compatible with the purpose for which the records were collected.
•
Information may be disclosed to the National Archives and Records Administration in records management inspections.
•
Information may be disclosed to contractors, grantees, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, job, or other activity for the Agency and who have a need to have access to the information in the performance of their duties or activities for the Agency.
•
Information from this system of records may be disclosed to an authorized appeal grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator or other person properly engaged in investigation or settlement of an administrative grievance, complaint, claim, or appeal filed by an employee, but only to the extent that the information is relevant and necessary to the proceeding. Agencies that may obtain information under this routine use include, but are not limited to, the Office of Personnel Management, Office of Special Counsel, Merit Systems Protection Board, Federal Labor Relations Authority, Equal Employment Opportunity Commission, and Office of Government Ethics.
•
Information from this system of records may be disclosed in connection with litigation or settlement discussions regarding claims by or against the EPA, including public filing with a court, to the extent that disclosure of the information is relevant and necessary to the litigation or discussions and except where court orders are otherwise required under section (b)(11) of the Privacy Act of 1974, 5 U.S.C. 552a(b)(11).
•
To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that there has been a breach of the system of records, (2) the Agency has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Agency (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Agency's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
•
To another Federal agency or Federal entity, when the Agency determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
SNOW records are stored in a controlled access facility, inside of a controlled area, using self-encrypting hard drives. ServiceNow, Inc. has deployed a High-Availability architecture to ensure continuous business operations for the ServiceNow platform. There are two data centers supporting Government customers with one configured as the active and the other as the standby. The active and standby facilities are mirrored, which enables the standby to become the active site in the event of a disaster. Both data centers are mirrors of each other, and therefore they act as both an active and a standby facility. In addition to the mirror backup between the two instances, a local backup is kept at each site. Each local backup acts as the offsite backup for their counterpart dedicated data center cage. Backups are performed on disk through network-attached storage and are never written to tape. In addition to backups within each dedicated data center cage facility, a backup of each internal production instance is copied over to the standby site (Disaster Recovery site).
Records for EPA ServiceNow will be retrieved by customer first and last name, email address or by ticket reference number.
SNOW follows the EPA Records Policy for retention and disposal, per schedule 1012 (Information and Technology Management) and schedule 1049 (Information Access and Protection Records).
ServiceNow is a Cloud-Based Software as a Service (SaaS) solution designed to be accessed over the internet. As such, all remote communication must be encrypted, use for non-business purposes is prohibited and all users are required to be authorized. To verify that a user is authorized, EPA ServiceNow customers and staff must have a current valid EPA Active Directory account. External requestors (
Individuals seeking access to information in this system of records about themselves should make a written request to the Agency Privacy Officer, 1200 Pennsylvania Ave., Mailcode 2831T, Washington, DC 20460. Requesters are required to provide adequate identification (
Requests for correction or amendment must identify the record to be changed and the corrective action sought to the Agency Privacy Officer, 1200 Pennsylvania Ave., Mailcode 2831T, Washington, DC 20460;
Any individual who wants to know whether this system of records contains a record about themselves should submit a request to the Agency Privacy Officer, MC 2831T, 1200 Pennsylvania Avenue NW, Washington, DC 20460 or
None.
None.
Environmental Protection Agency (EPA).
Notice of settlement.
Under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency (EPA) has entered into a settlement agreement with Metropolitan Life Insurance Company and Smith International, Inc. concerning the Chemform, Inc., Superfund Site located in Pompano Beach, Florida. The settlement addresses recovery of CERCLA costs for a cleanup action performed by the EPA at the Site.
The Agency will consider public comments on the settlement until July 11, 2019. The Agency will consider all comments received and may modify or withdraw its consent to the proposed settlement if comments received disclose facts or considerations which indicate that the proposed settlement is inappropriate, improper, or inadequate.
Copies of the settlement are available from the Agency by contacting Ms. Paula V. Painter, Program Analyst, using the contact information provided in this notice. Comments may also be submitted by referencing the Site's name through one of the following methods:
•
•
• Email:
Paula V. Painter at 404/562-8887.
The Office of the Federal Register received this document on June 6, 2019.
Environmental Protection Agency (EPA).
Request for Nominations to the National Environmental Justice Advisory Council (NEJAC).
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). The NEJAC was chartered to provide advice regarding broad, cross-cutting issues related to environmental justice. This notice solicits nominations to fill approximately seven (7) new vacancies for terms through November 2020. To maintain the representation outlined by the charter, nominees will be selected to represent: Academia (3 vacancies); community-based organizations (2 vacancies); non-governmental organizations (1 vacancy) and tribal governments and indigenous organizations (1 vacancy). Vacancies are anticipated to be filled by November 2019. Sources in addition to this
Nominations should be submitted in time to arrive no later than Monday, July 15, 2019.
Submit nominations electronically with the subject line NEJAC Membership 2019 to
Karen L. Martin, NEJAC Program Manager, U.S. EPA; email:
The NEJAC is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the NEJAC in 1993 to provide independent consensus advice to the EPA Administrator about a broad range of environmental issues related to environmental justice. The NEJAC conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related regulations.
The Council consists of 30 members (including a Chairperson and two Vice-Chairpersons) appointed by EPA's Administrator. Members serve as non-federal stakeholders representing: Six (6) from academia, four (4) from business and industry; seven (7) from community based organizations; six (6) from non-governmental/environmental organizations; four (4) from state and local governments; and three (3) from tribal governments and indigenous organizations, of which one member serves as a liaison to the National Tribal Caucus. Members are appointed for one (1), two (2) or three (3)-year terms with the possibility of reappointment for another term.
The NEJAC usually meets face-to-face twice a year, generally in the Spring and the Fall. Additionally, members may be asked to participate in teleconference meetings or serve on work groups to develop recommendations, advice letters, and reports to address specific policy issues. The average workload for members is approximately 5 to 8 hours per month. EPA provides reimbursement for travel and other incidental expenses associated with official government business.
Other criteria used to evaluate nominees will include:
• The background and experience that would help members contribute to the diversity of perspectives on the committee (
• demonstrated experience with environmental justice and community sustainability issues at the national, state, or local level;
• excellent interpersonal and consensus-building skills;
• ability to volunteer time to attend meetings 2-3 times a year, participate in teleconference meetings, attend listening sessions with the Administrator or other senior-level officials, develop policy recommendations to the Administrator, and prepare reports and advice letters; and
• willingness to commit time to the committee and demonstrated ability to work constructively and effectively on committees.
• Current contact information for the nominee/applicant, including the nominee's/applicant's name, organization (and position within that organization), current business address, email address, telephone numbers and the stakeholder category position you are interested in.
• Brief Statement describing the nominee's/applicant's interest in serving on the NEJAC.
• Résumé and a short biography describing the professional and educational qualifications of the nominee, including a list of relevant activities, and any current or previous service on advisory committees.
• Brief statements describing experience as it relates to engaging affected communities, understanding environmental justice/relevant issues, consensus building, communication skills and availability.
• Letter[s] of recommendation from a third party supporting the nomination. Letter[s] should describe how the nominee's experience and knowledge will bring value to the work of the NEJAC.
Other sources, in addition to this
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before August 12, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In 1995, via a Report and Order in PR Docket No. 93-61; FCC 95-41, published at 60 FR 15248, the Commission established construction deadlines for Location and Monitoring Service (LMS) licensees in the market-licensed multilateration LMS services. On July 8, 2004, the Commission adopted a Report and Order under WT Docket Nos. 02-381, 01-14, and 03-202; FCC 04-166, published at 69 FR 75144, that amended § 90.155 to provide holders of multilateration location service authorizations with five- and ten-year benchmarks to place in operation their base stations that utilize multilateration technology to provide multilateration location service to one-third of the Economic Area's (EA's) population within five years of initial license grant, and two-thirds of the population within ten years. At the five- and ten-year benchmarks, licensees are required to file a map and FCC Form 601 showing compliance with the coverage requirements pursuant to § 1.946 of the Commission's rules.
On January 31, 2007, via an Order on Reconsideration, and Memorandum Opinion and Order, under DA 07-479, the FCC granted two to three additional years to meet the five-year construction requirement for certain multilateration Location and Monitoring Service Economic Area licenses, and extended the 10-year requirement for such licenses two years.
These requirements will be used by Commission personnel to evaluate whether or not certain licensees are providing substantial service as a means of complying with their construction requirements, or have demonstrated that an extended period of time for construction is warranted.
Federal Communications Commission.
Notice.
The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for public information collection pursuant to the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the
Cathy Williams, Office of the Managing Director, at (202) 418-2918, or email:
The total annual reporting burdens and costs for the respondents are as follows:
On August 3, 2018, the Commission released a Report and Order (
Commission staff will use the applications, certified statements, and contracts submitted by potential incubating and incubated entities, along with any responses to Commission requests for additional information to determine qualifications for participation in the incubator program.
Commission staff will use the periodic reports to determine whether ongoing incubation relationships are proceeding in a manner consistent with the parties' initial filings and are likely to result in a successful incubation relationship. At the end of a successful incubation relationship, either the incubated entity will own and operate a full-service AM or FM station independently or the incubated station will be on a firmer footing if the station was struggling at the start of the relationship.
In the event the parties seek to extend the duration of their incubation relationship beyond the standard three-year term, the filing of a request for such an extension will enable Commission staff to gauge the types of problems incubating parties are experiencing. Information provided by the parties to the Commission no later than six months before the contract termination
Federal Communications Commission.
Notice of a Modified System of Records.
The Federal Communications Commission (FCC, Commission, or Agency) has modified an existing system of records, FCC/OET-1, Experimental Radio Station License Files (ELS), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the
This action will become effective on June 11, 2019. Written comments on the system's routine uses are due by July 11, 2019. The routine uses in this action will become effective on July 11, 2019, unless written comments are received that require a contrary determination.
Send comments to Leslie F. Smith, Privacy Manager, Information Technology (IT), Room 1-C216, Federal Communications Commission, 445 12th Street SW, Washington, DC 20554, or via the internet at
Leslie F. Smith, (202) 418-0217, or
FCC/OET-1 helps the FCC administer the Experimental Radio Service, which makes portions of the radio frequency spectrum available for the purposes of experimentation, product development, and market trials. This notice serves to modify FCC/OET-1 as a result of the various necessary changes and updates, including the introduction of an all-electronic information filing system, and other updates and modifications to meet current FCC and OMB requirements for SORNs, including format changes required by OMB Circular A-108, since its previous publication. The substantive changes and modifications to the previously published version of the FCC/OET-1 system of records include:
1. Updating the language in the Security Classification to follow OMB and FCC guidance.
2. Implementing minor changes to the language in the Categories of Individuals to be consistent with the language and phrasing now used in the FCC's SORNs.
3. Expanding the Categories of Records to include FCC Form 159 and Special Temporary Authorities; to add the name, mailing address, email address, and telephone number in the PII included in experimental project reports of applicants and/or licensees; to include comments from FCC bureaus and offices and the NTIA on both frequency interference potential and/or coordination of operations; and to include information pertaining to contested applications for licenses, transfers, assignments, and construction, or petitions to deny or to cancel applicants on behalf of other parties.
4. Expanding the Record Source Categories to note that the record sources include, but are not limited to the information that individual applicants provide on one or more FCC forms, special temporary authorities (STAs), and/or any supporting exhibits submitted by the applicants and/or licensees, and related documentation.
5. Updating and/or revising language in four routine uses: (2) Adjudication and Litigation; (3) Law Enforcement and Investigation; (4) Congressional Inquiries; and (5) Government-wide Program Management and Oversight.
6. Adding three new routine uses: (6) Breach Notification to address real or suspected data breach situations at the FCC; (7) Assistance to Federal Agencies and Entities for assistance with other Federal agencies' data breach situations; and (8) For Non-Federal Personnel to allow contractors performing or working on a contract for the Federal Government access to information. Routine Uses (6) and (7) are required by OMB Memorandum M-17-12.
7. Adding a new records retention and disposal schedule approved by the National Archives and Records Administration (NARA).
8. Adding two new sections: Reporting to a Consumer Reporting Agency addressing valid and overdue debts owed by individuals to the FCC under the Debt Collection Act, as recommended by OMB; and History referencing the previous publication of this SORN in the
The system of records is also updated to reflect various administrative changes related to the system managers and system addresses; policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and contesting records procedures.
FCC/OET-1, Experimental Radio Station License Files (ELS).
No information in the ELS system is classified. Experimental license applications that contain classified material are treated in a bifurcated manner, with unclassified data filed in ELS. The remaining portion of these applications are filed with the FCC's Security Operations Staff and are processed consistent with the FCC's security regulations. The material filed with the Security Operations Staff is maintained separately from and does not become part of the ELS system.
Office of Engineering and Technology (OET), Federal Communications Commission (FCC), 445 12th Street SW, Washington, DC 20554.
Experimental Licensing Branch, Office of Engineering and Technology (OET), Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
47 U.S.C. 308.
The uses for the information in the system include, but are not limited to those uses for which FCC employees may determine:
1. An applicant's eligibility to operate a station in the experimental radio service;
2. The interference potential to other radio services within the Commission; and/or
3. If the proposed project or experimentation falls within the type of permissible operations set forth in section 5.3 of the Commission's rules, 47 CFR 5.3.
The categories of individuals in this system include, but are not limited to, those who have applied for or have been granted a license to operate an experimental radio station under 47 CFR part 5 of the Commission's rules.
The categories of records in this system include, but are not limited to:
1. These FCC Forms, any supporting exhibits submitted by the applicant(s), and related documentation:
(a) FCC Form 159 series, Remittance Advice et al. (when paying fees by check);
(b) FCC Form 405, Application for Renewal of Station License;
(c) FCC Form 442, Application for a New or Modified Station;
(d) FCC Form 702, Application for Consent to Assignment of Radio Station Construction Authorization or License;
(e) FCC Form 703, Application for Consent to Transfer Control of Corporation Holding Station License;
(f) Special Temporary Authority (STA) under 47 CFR 5.61 of the Commission's rules; and
(g) Any supporting documentation, including but not limited to exhibits and other materials submitted by the applicant(s) and/or licensee(s).
2. Personally identifiable information (PII) included in experimental project reports submitted by the applicant(s) and/or licensee(s) as required by 47 CFR part 5 of the Commission's rules, including name, mailing address, email address(es), and telephone number(s).
3. Information included in comments from other FCC bureaus/offices and the NTIA on frequency interference potential and/or coordination of the operation(s).
4. Contested applications for licenses, transfers, assignments, and construction, or petitions to deny or to cancel applicants on behalf of other parties.
5. Comments from other FCC bureaus/offices on whether the project or experimentation is valid, as well as its possible use in rulemakings.
The sources for the majority of information in this system of records include, but are not limited to the information that individual applicants provide on one or more FCC forms, special temporary authorities (STAs), and/or any supporting exhibits submitted by the applicants and/or licensees, and related documentation. Other information in these records comes from coordination with other FCC bureaus and offices from data that are generated with the OET Spectrum Coordination Branch during the normal processing of the application.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside the FCC as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. Public Access—Information from this system is posted at:
2. Adjudication and Litigation—To disclose information to the Department of Justice (DOJ), or other administrative body before which the FCC is authorized to appear when: (a) The FCC or any other component thereof; or (b) any employee of the FCC in his or her official capacity; or (c) any employee of the FCC in his or her individual capacity where the DOJ or the FCC have agreed to represent the employee; or (d) the United States is a party to litigation or have an interest in such litigation, and the use of such records by the DOJ or the FCC is deemed by the FCC to be relevant and necessary to the litigation.
3. Law Enforcement and Investigation—To disclose pertinent information to the appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation or order, where the FCC becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation.
4. Congressional Inquiries—To provide information to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the written request of that individual.
5. Government-wide Program Management and Oversight—To disclose information to the National Archives and Records Administration (NARA) for use in its records management inspections; to the Government Accountability Office (GAO) for oversight purposes; to the Department of Justice (DOJ) to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or to the Office of Management and Budget (OMB) to obtain that office's advice regarding obligations under the Privacy Act.
6. Breach Notification—To appropriate agencies, entities, and persons when: (a) The Commission suspects or has confirmed that there has been a breach of the system of records; (b) the Commission has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Commission (including its information systems, programs, and operations), the Federal Government, or national security; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
7. Assistance to Federal Agencies and Entities—To another Federal agency or Federal entity, when the Commission determines that information from this system is reasonably necessary to assist the recipient agency or entity in: (a) Responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, program, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
8. For Non-Federal Personnel—To disclose information to contractors performing or working on a contract for OET that provides services for the Federal Government who may require access to this system of records.
In addition to the routine uses listed above, the Commission may share information from this system of records with a consumer reporting agency regarding an individual who has not paid a valid and overdue financial debt owed to the Commission, following the procedures set out in the Debt Collection Act, 31 U.S.C. 3701(e).
Information in this system of records includes:
1. Paper records, files, and documents are maintained for various, short-term uses, as necessary. These documents are maintained in file cabinets in the OET office suite. The file cabinets are locked at the end of the business day. These documents are destroyed by shredding when no longer needed.
2. Electronically scanned images of paper documents and records;
3. Electronic records of data elements of both paper applicants and files and electronically filed applications; and
4. Electronic copies of licenses granted after November 16, 1998.
As required by 47 CFR 5.55(b) of the Commission's rules, all applications for experimental licensing must now be filed electronically via the internet at:
1. The paper documents, files, and records are retrieved by the licensee name. If there is more than one station per licensee, then the files may be also retrieved by call sign; and
2. The scanned images, electronic records of data elements, and electronic copies of licenses may be retrieved from the OET Experimental Licensing Branch Report World Wide Web electronic filing and reporting site at:
The information in this system is maintained and disposed of in accordance with the National Archives and Records Administration (NARA) General Records Schedule DAA-0173-2016-0003. The records, documents, and files are maintained for three years after expiration of the license. The FCC disposes of the paper documents by shredding. The electronic records, files, and data are destroyed either by physical destruction of the electronic storage media or by erasure of the electronic data.
OET makes all records, documents, and files (including both paper and electronic formats) available to the public at:
When not publicly available, the electronic data, records, and files are stored within FCC accreditation boundaries. Access to the electronic files is restricted to OET and IT staff, contractors, and vendors who maintain the networks and services. Other FCC employees, contractors, vendors, and users may be granted access on a need-to-know basis. The FCC's data are protected by the FCC and third-party privacy safeguards, a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal IT privacy standards, including those required by the Federal Information Security Modernization Act of 2014 (FISMA), the Office of Management and Budget (OMB), and the National Institute of Standards and Technology (NIST).
The OET staff may print paper copies of these electronic records for various, short-term uses, as necessary. These paper document copies are stored in locked file cabinets in the OET office suite, when not in use. Only authorized OET staff and contractors may have access to these documents, unless OET grants access to FCC employees and contractors, as required, for specific purposes. These paper documents are destroyed by shredding when no longer needed.
Individuals wishing to request access to and/or amendment of records about them should follow the Notification Procedure below.
Individuals wishing to request access to and/or amendment of records about them should follow the Notification Procedure below.
Individuals wishing to determine whether this system of records contains information about them may do so by writing to Leslie F. Smith, Privacy Manager, Information Technology, Federal Communications Commission, 445 12th Street SW, Washington, DC 20554, or email
Individuals must furnish reasonable identification by showing any two of the following: Social security card; passport; driver's license; employee identification card; Medicare card; birth certificate; bank credit card; and/or other positive means of identification, or by signing an identity statement stipulating that knowingly or willfully seeking or obtaining access to records about another person under false pretenses is punishable by a fine of up to $5,000.
Individuals requesting access must also comply with the FCC's Privacy Act regulations regarding verification of identity and access to records, 47 CFR part 0, subpart E.
None.
The FCC previously gave full notice of FCC/OET-1, Experimental Radio Station License Files (ELS), by publication in the
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 5, 2019.
1.
Federal Trade Commission.
Proposed consent agreement; request for comment.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before July 11, 2019.
Interested parties may file comments online or on paper, by following the instructions in the Request for Comment part of the
Carl H. Settlemyer (202-326-2019), Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for June 3, 2019), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 11, 2019. Write “Shore to Please Vacations LLC; File No. 182 3088” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online through the
If you prefer to file your comment on paper, write “Shore to Please Vacations LLC; File No. 182 3088” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC website at
The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an agreement containing a consent order as to Shore to Please Vacations LLC and Robert A. Stephens (“respondents”).
The proposed consent order (“order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After the comment period ends, the Commission will again review the order and the comments received, and will decide whether it should withdraw the order or make it final.
This matter involves the respondents' use of non-disparagement provisions in consumer form contracts in the course of renting vacation properties. The complaint alleges that the respondents violated Section 2(c) of the Consumer Review Fairness Act (“CRFA”) by offering to consumers form contracts that contained non-disparagement provisions made void by Section 2(b) of the CRFA. The CRFA defines a form contract as a contract with standardized terms, used in the course of selling or leasing goods or services, and imposed on an individual without a meaningful opportunity for such individual to negotiate the standardized terms.
The order includes injunctive relief that prohibits these alleged violations and fences in similar and related conduct involving the use of contract terms that prohibit, restrict, penalize, or transfer rights in consumer reviews or evaluation of the respondents, their goods, or their services. The CRFA authorizes the Commission to seek civil penalties for knowing violations, but the complaint does not allege that the respondents' violations were knowing, and the order does not provide for monetary relief.
Part I prohibits, in the sale or leasing of any good or service, the respondents from: Offering to any prospective customer a contract, or offering to any customer a renewal contract, that includes a review-limiting term; requiring that a customer accept such a term as a condition of the respondents' fulfillment of their obligations under contracts entered into before the effective date of the order; or attempting to enforce or assert the validity of such a term in customer contracts entered into before the effective date of the order. Part I would not require that the respondents publish or host the content of any person, affect any other legal duty of a party to a contract, or affect any cause of action arising from the breach of such duty.
Part II requires the respondents to notify by mail or email customers with whom they entered into form contracts with a non-disparagement provision on or after March 14, 2017 that the non-disparagement provision is void and cannot be enforced, and that those customers can publish their honest reviews about the respondents, even if their comments are negative.
Part III requires that the respondents dismiss their remaining count against a renter for alleged breach of the non-disparagement provision.
Part IV requires the respondents to submit signed acknowledgments that relevant personnel received the order.
Part V requires the respondents to file compliance reports with the Commission, and to notify the Commission of bankruptcy filings or changes in company structure that might affect compliance obligations.
Part VI contains recordkeeping requirements for personnel records, consumer contracts, communications with consumers threatening any legal action relating to any review; and court filings and the company's discovery responses in legal actions over consumer reviews, as well as all records necessary to demonstrate compliance or non-compliance with the order.
Part VII contains other requirements related to the Commission's monitoring of the respondent's order compliance.
Part VIII provides the effective dates of the order, including that, with exceptions, the order will terminate in 20 years.
The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order's terms in any way.
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement; request for comment.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before July 11, 2019.
Interested parties may file comments online or on paper, by following the instructions in the Request for Comment part of the
Carl H. Settlemyer (202-326-2019), Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for June 3, 2019), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 11, 2019. Write “Staffordshire Property Management, LLC; File No. 182 3084” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online through the
If you prefer to file your comment on paper, write “Staffordshire Property Management, LLC; File No. 182 3084” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC website at
The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an agreement containing a consent order as to Staffordshire Property Management, LLC and Aaron Fischer (“respondents”).
The proposed consent order (“order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After the comment period ends, the Commission will again review the order and the comments received, and will decide whether it should withdraw the order or make it final.
This matter involves the respondents' use of non-disparagement provisions in consumer form contracts in the course of processing the applications of prospective tenants to rent residential properties that respondents manage. The complaint alleges that the respondents violated Section 2(c) of the Consumer Review Fairness Act (“CRFA”) by offering to consumers form contracts that contained non-disparagement provisions made void by Section 2(b) of the CRFA. The CRFA defines a form contract as a contract with standardized terms, used in the course of selling or leasing goods or services, and imposed on an individual without a meaningful opportunity for such individual to negotiate the standardized terms.
The order includes injunctive relief that prohibits these alleged violations and fences in similar and related conduct involving the use of contract terms that prohibit, restrict, penalize, or transfer rights in consumer reviews or evaluation of the respondents, their goods, or their services. The CRFA authorizes the Commission to seek civil penalties for knowing violations, but the complaint does not allege that the respondents' violations were knowing, and the order does not provide for monetary relief.
Part I prohibits, in the sale or leasing of any good or service, the respondents from: Offering to any prospective customer a contract, or offering to any customer a renewal contract, that includes a review-limiting term; requiring that a customer accept such a term as a condition of the respondents' fulfillment of their obligations under contracts entered into before the effective date of the order; or attempting to enforce or assert the validity of such a term in customer contracts entered into before the effective date of the order. Part I would not require that the respondents publish or host the content of any person, affect any other legal duty of a party to a contract, or affect any cause of action arising from the breach of such duty.
Part II requires the respondents to notify customers via letters or emails, and via their website, that the non-disparagement provisions in their form contracts are void and cannot be enforced, and that customers who entered into contracts with those provisions can publish their honest reviews about the respondents, even if their comments are negative.
Part III requires the respondents to submit signed acknowledgments that relevant personnel received the order.
Part IV requires the respondents to file compliance reports with the Commission, and to notify the Commission of bankruptcy filings or changes in company structure that might affect compliance obligations.
Part V contains recordkeeping requirements for personnel records, consumer contracts, communications with consumers threatening any legal action relating to any review; and court filings and the company's discovery responses in legal actions over consumer reviews, as well as all records necessary to demonstrate compliance or non-compliance with the order.
Part VI contains other requirements related to the Commission's monitoring of the respondent's order compliance.
Part VII provides the effective dates of the order, including that, with
The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order's terms in any way.
By direction of the Commission.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice of cancellation.
This notice announces the cancellation of GSA Federal Management Regulation (FMR) Bulletin B-32.
For clarification of content or information, contact Mr. James Vogelsinger, Director, Office of Government-wide Policy, Office of Asset and Transportation Management at (202) 501-1764 or via email at
On May 24, 2011, the President issued a Presidential Memorandum on Federal Fleet Performance. This memorandum stated that any executive fleet vehicles that are larger than a midsize sedan or do not comply with alternative fueled vehicle (AFV) requirements must be disclosed on agency websites. On October 12, 2011, GSA provided guidance to agencies regarding the identification of executive fleet vehicles and the requirements to post them on agency websites by issuing FMR Bulletin B-32. On March 19, 2015, Executive Order 13693, Planning for Federal Sustainability in the Next Decade was signed which revoked the May 24, 2011 Presidential Memorandum on Federal Fleet Performance, effective as of October 1, 2015. Therefore, the requirement for any executive fleet vehicles that are larger than a midsize sedan or do not comply with AFV requirements to be disclosed on agency websites no longer exists.
Bulletins regarding motor vehicle management are located on the internet at
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice.
This notice announces the cancellation of GSA Federal Management Regulation (FMR) Bulletin B-30.
Mr. James Vogelsinger, Office of Government-wide Policy, Office of Asset and Transportation Management at (202) 501-1764 or via email at
GSA Bulletin FMR B-9 was issued on August 26, 2005. The Bulletin provided guidance to Executive Branch agencies on the development and maintenance of a documented Vehicle Allocation Methodology for agency fleets. GSA Bulletin FMR B-30 cancelled FMR Bulletin B-9, effective August 22, 2011. GSA Bulletin FMR B-43 subsequently superseded FMR Bulletin B-30, effective March 20, 2017. This cancellation of GSA FMR Bulletin B-30 clarifies that GSA FMR Bulletin B-43 is the only guidance on Vehicle Allocation Methodology in effect currently.
Bulletins regarding motor vehicle management are located on the internet at
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
This proposed information collection was previously published in the
Comments on this notice must be received on or before 30 days after date of publication.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
The Hospital Survey on Patient Safety Culture (Hospital SOPS) is designed to enable hospitals to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The Hospital SOPS includes 42 items that measure 12 composites of patient safety culture. AHRQ first made the Hospital SOPS publicly available, along with a Survey User's Guide and other toolkit materials, in November 2004 on the AHRQ website.
The Hospital Survey on Patient Safety Culture Comparative Database (Hospital SOPS Database) consists of data from
This database will:
(1) Present results from hospitals that voluntarily submit their data,
(2) provide data to hospitals to facilitate internal assessment and learning in the patient safety improvement process, and
(3) provide supplemental information to help hospitals identify their strengths and areas with potential for improvement in patient safety culture.
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to surveys and database development. 42 U.S.C 299a(a)(1) and (8)
To achieve the goal of this project the following activities and data collections will be implemented:
(1)
(2)
(3)
(4)
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 340 POCs, each representing an average of 3 individual hospitals each, will complete the database submission steps and forms annually. Each POC will submit the following:
• Eligibility and registration form (completion is estimated to take about 3 minutes).
• Data Use Agreement (completion is estimated to take about 3 minutes).
• Hospital Information Form (completion is estimated to take about 5 minutes).
• Survey data submission will take an average of one hour.
The total annual burden hours are estimated to be 459 hours. Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $26,572 annually.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “
This proposed information collection was previously published in the
Comments on this notice must be received on or before 30 days after date of publication.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
The Agency for Healthcare Research and Quality (AHRQ) requests to revise and extend the currently approved
The 2017 OMB clearance included one response for the Structural Assessment and the
As part of the Department of Health and Human Services (DHHS) Hospital Acquired Infection (HAI) National Action Plan (NAP), AHRQ has supported the implementation and adoption of the Comprehensive Unit-based Safety Program (CUSP) to reduce Central-Line Associated Bloodstream Infections (CLABSI) and Catheter-Associated Urinary Tract Infections (CAUTI), and subsequently applied CUSP to other clinical challenges, including reducing surgical site infections and improving care for mechanically ventilated patients. As part of the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) to increase antibiotic stewardship (defined as organized efforts to promote the judicious use of
Antibiotic therapy has saved countless lives over the past several decades. However, bacterial resistance to antibiotics has followed closely on the heels of each new agent's introduction. This has led to an epidemic of antibiotic resistance, with drug choices for some bacterial infections becoming increasingly limited, expensive, and in some cases nonexistent. While antibiotics remain a vital and necessary cornerstone to the treatment of infections, it is estimated that 20-50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate. When antibiotics are used inappropriately, bacterial development of resistance is supported in the
While approaches including development of new antibiotic agents, increased surveillance for antibiotic resistance, prevention of HAIs, and prevention of transmission of resistant infections are important efforts to combat antibiotic resistance, it is critical to curb the inappropriate use of antibiotics to slow the emergence of antibiotic resistance and to preserve efficacy of existing antibiotics and those under development.
As of January 1st, 2017, The Joint Commission (TJC)'s new Antimicrobial Stewardship Standard requires that all acute care hospitals have robust antibiotic stewardship programs. In addition, starting on November 28, 2017, the Centers for Medicare & Medicaid Services (CMS) required that all long-term care facilities that receive reimbursement from CMS have antibiotic stewardship programs in place.
The Comprehensive Unit-Based Safety Program (CUSP), developed at the Armstrong Institute at Johns Hopkins University, combines improvement in patient safety culture, teamwork, and communication together with a technical bundle of interventions to improve patient safety. CUSP is a powerful culture change tool, which has been successfully utilized to reduce CLABSI in ICUs in Michigan and Rhode Island and subsequently to reduce CLABSI by 41% in more than 1,000 ICUs in 44 states, Puerto Rico and the District of Columbia. Although evidence-based recommendations for prevention of CLABSI had existed for years, the combination of safety culture change on units and implementation of technical interventions resulted in significant reductions in CLABSI and introduced the concept that a rate of zero CLABSIs is achievable. CUSP is also being used to reduce other HAIs in multiple settings (
This project will assist hospitals, nursing homes, and ambulatory care sites across the United States in adopting and implementing AS programs and interventions.
This project has the following goals:
The project will be implemented in four cohorts; (1) Cohort 1 is a pilot limited to 10 facilities each in three integrated delivery systems spanning acute care, long-term care, and ambulatory settings; (2) Cohort 2 will expand to include 250-500 acute care hospitals; (3) Cohort 3 will include 250-500 long-term care facilities; and (4) Cohort 4 will include 250-500 ambulatory care facilities.
The AHRQ Safety Program is being undertaken pursuant to AHRQ's mission to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. 42 U.S.C. 299.
To achieve the goals of the AHRQ Safety Program, the following data collections will be implemented:
(1)
(2)
(3)
a. The
b. The
c. The
(4)
Exhibit A.1 shows the estimated annualized burden hours for the respondents' time to complete the Structural Assessments, Team Antibiotic Review Forms, AHRQ Patient Safety Culture Surveys, semi-structured qualitative interviews, and EHR data extractions. Data will be collected from 30 acute care, long-term care, and ambulatory care sites during the Cohort 1 one-year pilot period; up to 500 acute care hospitals in Cohort 2; up to 500 long-term care facilities in Cohort 3; and up to 500 ambulatory care sites in Cohort 4. With this revision, the total estimated annualized burden hours for the data collection activities are 27,064.
Exhibit A.2 shows the estimated annualized cost burden based on the respondents' time to complete the data collection forms. The total cost burden is estimated to be $1,311,096.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAXDELA IV INJECTION under new drug application (NDA) 208611 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved NDA 208611 for marketing the human drug product, BAXDELA IV INJECTION (delafloxacin meglumine) indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by designated susceptible bacteria. Subsequent to the approval, the USPTO received patent term restoration applications for BAXDELA (U.S. Patent Nos. 7,728,143 and 8,252,813) from Melinta Therapeutics, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 2, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approvals of BAXDELA TABLETS and BAXDELA IV INJECTION represent the first permitted commercial marketing or use of the products. Thereafter, the USPTO requested that FDA determine the products' regulatory review period.
FDA has determined that the applicable regulatory review period for BAXDELA IV INJECTION is 5,813 days. Of this time, 5,569 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,307 or 1,001 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of July 11, 2019.
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 11, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on July 11, 2019 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISQALI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product KISQALI (ribociclib succinate). KISQALI, in combination with an aromatase inhibitor as initial endocrine-based therapy, is indicated for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Subsequent to this approval, the USPTO received patent term restoration applications for KISQALI (U.S. Patent Nos. 8,324,225; 8,415,355; 8,685,980; 8,962,630; and 9,416,136) from Novartis AG and Astex Therapeutics Ltd., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 6, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of KISQALI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for KISQALI is 2,393 days. Of this time, 2,196 days occurred during the testing phase of the regulatory review period, while 197 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 879 days, 22 days, 292 days, 459 days, or 204 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability; reopening of comment period.
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled “Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability” that appeared in the
FDA is reopening the comment period for the notice published on February 27, 2019 (84 FR 6403). Submit either electronic or written comments on the draft guidance by August 12, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-
Sau L. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 301-796-2905.
In the
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) 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.
Fax written comments on the collection of information by July 11, 2019.
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: 202-395-7285, or emailed to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports FDA regulations. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act, certain provisions have been established to protect against the intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk. These provisions are codified at part 121 (21 CFR part 121), and include requirements that an owner, operator, or agent in charge of a facility must:
• Prepare and implement a written food defense plan that includes a vulnerability assessment to identify significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification (§ 121.126);
• identify any significant vulnerabilities and actionable process steps by conducting a vulnerability assessment for each type of food manufactured, processed, packed, or held at the facility using appropriate methods to evaluate each point, step, or procedure in a food operation (§ 121.130);
• identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. For each mitigation strategy implemented at each actionable process step, include a written explanation of how the mitigation strategy sufficiently minimizes or prevents the significant vulnerability associated with the actionable process step (§ 121.135);
• establish and implement mitigation strategies management components, as appropriate to ensure the proper implementation of each such mitigation strategy, taking into account the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.138);
• establish and implement food defense monitoring procedures, for monitoring the mitigation strategies, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.140);
• establish and implement food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented, as appropriate to the nature of the actionable process step and the nature of the mitigation strategy (§ 121.145);
• establish and implement specified food defense verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.150);
• conduct a reanalysis of the food defense plan (§ 121.157);
• ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties (§ 121.4); and
• establish and maintain certain records, including the written food defense plan (vulnerability assessment, mitigation strategies and procedures for food defense monitoring, corrective actions, and verification) and documentation related to training of personnel. All records are subject to certain general recordkeeping and record retention requirements (§§ 121.301 to 121.330).
In the
While we continue to invite comment regarding our burden estimates, we note that they reflect what we believe is representative of the industry average. This information collection covers numerous respondents with varying facility sizes and with differing product inventories. As compliance with the regulatory requirements continues to take effect, we will continue to evaluate the associated information collection burden accordingly. Although we always appreciate feedback regarding ways to improve efficiencies associated with our information collection activities, we decline to adopt alternative burden estimates for the information collection at this time. Rather, we retain the current estimates, which are as follows:
Certain facilities may qualify for an exemption under the regulations. Because these facilities must provide documentation upon request to verify their exempt status, we have characterized this as a reporting burden. We estimate 18,080 respondents will prepare and update relevant files an average of 30 minutes annually, for a total annual burden of 9,040 hours (30 minutes × 18,080 firms).
Under the regulations, an owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food defense plan, including written identification of actionable process steps, written mitigation strategies, written procedures for defense monitoring, written food defense corrective actions, and written food defense verification procedures. The estimated recordkeeping burden associated with these activities totals 2,516,482 annual recordkeeping burden hours and 409,486 annual recordkeeping responses.
We estimate an average of 3,247 firms will continue to need to create a food defense plan under § 121.126, that a one-time burden of 60 hours will be needed to create a plan, and that a burden of 10 hours will be required to update the plan. We annualize this estimate by dividing the total number of burden hours (70) over a 3-year period as reflected in table 2, row 1.
Under § 121.130, each of the estimated 9,759 food production facilities will identify and specify actionable process steps for its food defense plan. We estimate that an individual at the level of an operations manager incurs a burden of 20 hours for this activity, as reflected in table 2, row 2.
Under § 121.135(b), each of the estimated 9,759 food production facilities must identify and implement mitigation strategies to provide assurances that any significant vulnerability at each step is significantly minimized or prevented, ensuring that the food manufactured, processed, packed, or held by the facility will not be adulterated. We do not specify a specific number or set of mitigation strategies to be implemented. Some of the covered facilities are already implementing mitigation strategies. We estimate that it requires an average of 20 hours per facility to satisfy the recordkeeping burden associated with these activities for a total of 195,180 hours, as reflected in table 2, row 3.
We estimate that the recordkeeping activities associated with monitoring, documenting mitigation strategies, and implementing necessary corrective actions require first-line supervisors or others responsible for quality control an average of 175 hours for each recordkeeping, and that these provisions apply to each of the 9,759 facilities. This results in a total of 1,707,825 annual burden hours, as reflected in table 2, row 4.
We estimate that recordkeeping activities associated with training under § 121.4 total 244,802 annual burden hours, as reflected in table 2, row 5. We estimate that there are 1.2 million employees working at the regulated facilities and that 30 percent of them (367,203) require training. We estimate that the average burden for the associated recordkeeping activity is approximately 40 minutes (or 0.67 hours) per record.
Finally, we estimate the 9,759 food production facilities will fulfill the recordkeeping requirements under §§ 121.305 and 121.310, and that it will require an average of 10 hours per record, as reflected in table 2, row 6.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved NDA 208610 for marketing the human drug product, BAXDELA TABLETS (delafloxacin meglumine) indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by
FDA has determined that the applicable regulatory review period for BAXDELA TABLETS is 5,813 days. Of this time, 5,569 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates:
NDA 208610:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,307 or 1,001 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
NIZORAL (ketoconazole) topical cream, 2%, is the subject of NDA 019084, previously held by Johnson & Johnson Pharmaceutical Research and Development, LLC and initially approved on December 31, 1985. NIZORAL is indicated for the topical treatment of tinea corporis, tinea cruris, and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum; of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); of cutaneous candidiasis caused by Candida spp.; and of seborrheic dermatitis.
In a letter dated August 25, 2004, Johnson & Johnson Pharmaceutical Research and Development, LLC requested withdrawal of NDA 019084 for NIZORAL (ketoconazole) topical cream, 2%. In the
Arent Fox LLP submitted a citizen petition dated December 19, 2018 (Docket No. FDA-2018-P-4812), under 21 CFR 10.30, requesting that the Agency determine whether NIZORAL (ketoconazole) topical cream, 2%, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NIZORAL (ketoconazole) topical cream, 2%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NIZORAL (ketoconazole) topical cream, 2%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NIZORAL (ketoconazole) topical cream, 2%, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled “Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.” The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
The public workshop will be held on November 18, 2019, from 8 a.m. to 5 p.m., Eastern Time. See the
The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, B and C), Silver Spring, MD 20993-0002. Entrance for public workshop participants (non-FDA employees) is through Building 1 where routine security procedures will be performed. For parking and security information, please refer to:
Lauren Milligan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20993-0002, 240-402-6421, email:
Under FDARA, and in accordance with section I, part J of the PDUFA VI Performance Goals, FDA agreed to convene a series of workshops to identify best practices for MIDD (
PBPK modeling is a drug development tool that mathematically integrates physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug's absorption, distribution, metabolism, excretion, and pharmacokinetics (PK). Over the past several decades, there has been extensive research using PBPK modeling and simulation to address a wide range of clinical questions, such as exploring the effects of extrinsic factors (
FDA notes that PBPK modeling and simulation approaches are extensively used in regulatory submissions to predict the potential for drug-drug interactions and to support dosing recommendations for certain drugs when they are co-administered with metabolic enzyme modulators. However, challenges and knowledge gaps prevent PBPK modeling from being routinely used for specific regulatory decisions. Given the current limitations of the approach, it is important that the scientific community explore when, where, and how PBPK modeling and simulation may be applied in regulatory decision-making.
The objectives of the workshop are to:
1. Discuss “best practices” in integrating in vitro and in vivo data to develop PBPK models and developing evidentiary criteria
2. Share experiences and cases applying PBPK modeling and simulation that highlight the opportunities and limitations of this approach.
3. Obtain input from the stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making.
4. Discuss the knowledge gaps and research needs to advance PBPK modeling sciences in drug development and regulatory evaluation.
A detailed agenda will be posted in advance of the workshop at
Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m.
If you need special accommodations due to a disability, please contact Lauren Milligan (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALUNBRIG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, ALUNBRIG (brigatinib) indicated for treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Subsequent to this approval, the USPTO received a patent term restoration application for ALUNBRIG (U.S. Patent No. 9,012,462) from ARIAD Pharmaceutials, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated February 2, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ALUNBRIG represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ALUNBRIG is 2,105 days. Of this time, 1,862 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 81 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by August 12, 2019.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4)
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect information regarding investigational devices and establishes rules under which new medical devices may be tested using human subjects in a clinical setting. The Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) added section 520(g)(6) to the FD&C Act and permitted changes to be made to either the investigational device or to the clinical protocol without FDA approval of an investigational device exemption (IDE) supplement. An IDE allows a device, which would otherwise be subject to provisions of the FD&C Act, such as premarket notification or premarket approval, to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. The purpose of part 812 (21 CFR part 812) is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use. The IDE regulation is designed to encourage the development of useful medical devices and allow investigators the maximum freedom possible, without jeopardizing the health and safety of the public or violating ethical standards. To do this, the regulation provides for different levels of regulatory control, depending on the level of potential risk the investigational device presents to human subjects.
Investigations of significant risk devices, ones that present a potential for serious harm to the rights, safety, or welfare of human subjects, are subject to the full requirements of the IDE regulation. Nonsignificant risk device investigations,
Upon approval of an IDE application by FDA, a sponsor must submit certain requests and reports. Under § 812.35, a sponsor who wishes to make a change in the investigation that affects the scientific soundness of the study or the rights, safety, or welfare of the subjects, is required to submit a request for the change to FDA. Section 812.150 requires a sponsor to submit reports to FDA. These requests and reports are submitted to FDA as supplemental applications. This information is needed for FDA to assure protection of human subjects and to allow review of the study's progress. Section 812.36(c) identifies the information necessary to file a treatment IDE application. FDA uses this information to determine if wider distribution of the device is in the interest of the public health. Section 812.36(f) identifies the reports required to allow FDA to monitor the size and scope of the treatment IDE, to assess the sponsor's due diligence in obtaining marketing clearance of the device, and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for investigators and sponsors. FDA requires this information for tracking and oversight purposes. Investigators are required to maintain records, including correspondence and reports concerning the study, records of receipt, use or disposition of devices, records of each subject's case history and exposure to the device, informed consent documentation, study protocol, and documentation of any deviation from the protocol. Sponsors are required to maintain records including correspondence and reports concerning the study, records of shipment and disposition, signed investigator agreements, adverse device effects information, and, for a nonsignificant risk device study, an explanation of the nonsignificant risk determination, records of device name and intended use, study objectives, investigator information, investigational review board information, and statement on the extent that good manufacturing practices will be followed.
For a nonsignificant risk device investigation, the investigators' and sponsors' recordkeeping and reporting burden is reduced. Pertinent records on the study must be maintained by both parties, and reports are made to sponsors and institutional review boards (IRBs). Reports are made to FDA only in certain circumstances,
The estimate of the burden is based on the number of IDEs received in recent years.
FDA estimates the burden of this collection of information as follows:
Our estimated burden for the information collection reflects an overall decrease of 528 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years.
Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, President's Council on Sports, Fitness, and Nutrition.
Notice of collaboration; correction.
The Department of Health and Human Services published a document in the
Ms. Holli M. Richmond, Executive Director, Office of the President's Council on Sports, Fitness, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567.
In the
To receive consideration, a request to participate as a collaborating organization must be received via email or postmarked mail at the addresses listed below, by 5:00 p.m. EST on Thursday, June 20, 2019.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Vaccines Against Microbial Diseases Study Section, June 13, 2019, 8:30 a.m. to June 14, 2019, 5:00 p.m., Hilton Garden Inn, Washington, DC, Franklin Square, 815 14th Street NW, Washington, DC 20005, which was published in the
The meeting will be held at The Hilton Garden Inn Washington DC/Georgetown, 2201 M Street NW, Washington, DC 20037. The meeting date and time remain the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel; Member Conflict: Radiation Therapeutics and Biology, June 14, 2019, 12:00 p.m. to June 14, 2019, 3:00 p.m., which was published in the
The meeting location is being changed to National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Meeting dates remain the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material,
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1112.
42 CFR part 8 establishes a certification program managed by SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation requires that Opioid Treatment Programs (OTPs) be certified. “Certification” is the process by which SAMHSA determines that an OTP is qualified to provide opioid treatment under the Federal opioid treatment standards established by the Secretary of Health and Human Services. To become certified, an OTP must be accredited by a SAMHSA-approved accreditation body. The regulation also provides standards for such services as individualized treatment planning, increased medical supervision, and assessment of patient outcomes. This submission seeks continued approval of the information collection requirements in the regulation and of the forms used in implementing the regulation.
SAMHSA currently has approval for the Application for Certification to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11 (Form SMA-162); the Application for Approval as Accreditation Body Under 42 CFR 8.3(b) (Form SMA-163); and the Exception Request and Record of Justification Under 42 CFR 8.12 (Form SMA-168), which may be used on a voluntary basis by physicians when there is a patient care situation in which the physician must make a treatment decision that differs from the treatment regimen required by the regulation. Form SMA-168 is a simplified, standardized form to facilitate the documentation, request, and approval process for exceptions.
SAMHSA believes that the recordkeeping requirements in the regulation are customary and usual practices within the medical and rehabilitative communities and has not calculated a response burden for them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11 and 8.12 include maintenance of the following: 5-year retention by accreditation bodies of certain records pertaining to accreditation; documentation by an OTP of the following: A patient's medical examination when admitted to treatment, A patient's history, a treatment plan, any prenatal support provided the patient, justification of unusually large initial doses, changes in a patient's dosage schedule, justification of unusually large daily doses, the rationale for decreasing a patient's clinic attendance, and documentation of physiologic dependence.
The rule also includes requirements that OTPs and accreditation organizations disclose information. For example, 42 CFR 8.12(e)(1) requires that a physician explain the facts concerning the use of opioid drug treatment to each patient. This type of disclosure is considered to be consistent with the common medical practice and is not considered an additional burden. Further, the rule requires, under Sec. 8.4(i)(1) that accreditation organizations shall make public their fee structure; this type of disclosure is standard business practice and is not considered a burden.
The tables that follow summarize the annual reporting burden associated with the regulation, including burden associated with the forms. There are no changes being made to the forms.
Send comments to Janet Heekin, SAMHSA Reports Clearance Officer, Room 15E21-B, 5600 Fishers Lane, Rockville, MD 20850
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1112.
These regulations meet the directive under 42 U.S.C. 10826(b) requiring the Secretary to promulgate final regulations to carry out the PAIMI Act (42 U.S.C. 10801
On January 1, each eligible state protection and advocacy (P&A) system is required to prepare an annual PAIMI Program Performance Report (PPR). Each annual PPR describes a P&A system's activities, accomplishments and expenditures to protect the rights of individuals with mental illness supported with payments from PAIMI program allotments during the most recently completed fiscal year. Each P&A system transmit a copy of its annual report to the Secretary (via SAMHSA) and to the State Mental Health Agency where the system is located per the PAIMI Act at 42 U.S.C. 10824(a). Each annual PPR must provide the Secretary with the following information:
• The number of (PAIMI-eligible) individuals with mental illness served;
• A description of the types of activities undertaken;
• A description of the types of facilities providing care or treatment to which such activities are undertaken;
• A description of the manner in which the activities are initiated;
• A description of the accomplishments resulting from such activities;
• A description of systems to protect and advocate the rights of individuals with mental illness supported with payments from PAIMI program allotments;
• A description of activities conducted by states to protect and advocate such rights;
• A description of mechanisms established by residential facilities for individuals with mental illness to protect such rights;
• A description of the coordination among such systems, activities, and mechanisms;
• Specification of the number of public and nonprofit P&A systems established with PAIMI program allotments; and
• Recommendations for activities and services to improve the protection and advocacy of the rights of individuals with mental illness and a description of the need for such activities and services that were not met by the state P&A systems established under the PAIMI Act due to resource or annual program priority limitations.
Each PAIMI grantee's annual PPR must include a separate section, prepared by its PAIMI Advisory Council (PAC), that describes the council's activities and its assessment of the state P&A system's operations per the PAIMI Act at 42 U.S.C. 10805(7).
In 2017, SAMHSA included the annual PAIMI PPR in the Web-based Block Grant Application System (WebBGAS). WebBGAS, SAMHSA's electronic data system, is used to collect grantee information for the following reasons:
(1) To meet the OMB requirements for data collection for mandatory (formula) grant programs;
(2) To comply with the annual program reporting requirements of the PAIMI Act, 42 U.S.C. 10801
(3) To simplify the submission of PAIMI Program data by the state P&A systems;
(4) To meet the Government Performance and Results Act (GPRA) requirements;
(5) To comply with the Government Accountability Office (GAO) evaluation recommendations that SAMHSA obtain information that closely measures the actual outcomes of the programs it funds;
(6) To reduce the grantee data collection burden by removing information that did not facilitate evaluation of a PAIMI grantee's programmatic and financial management systems;
(7) To provide immediate access to the PAIMI program data used to prepare a section of the Secretary's biennial report to the President, Congress, and National Council on Disability in accordance with the
(8) To improve SAMHSA's ability to create reports, analyze trends, and provide timely feedback to the P&A grantees when PPR revisions are needed.
On July 17, 2017, OMB approved SAMHSA's PPR and Advisory Council Report (Control No. 0930-0169, Expiration Date July 31, 2020). The burden estimate for the annual state
Send comments to Janet Heekin, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E21-B, Rockville, MD 20857
Coast Guard, DHS.
Notification of issuance of a certificate of alternative compliance.
The Coast Guard announces that the Fifth District, Chief of Prevention Division has issued a certificate of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for the towing vessel CAPE HATTERAS, Official Number (O.N.) 1293071, Master Boat Builders Hull Number 460. We are issuing this notice because its publication is required by statute. Due to its construction, purpose and service, the towing vessel CAPE HATTERAS cannot fully comply with the light, shape, or sound signal provisions of the 72 COLREGS without interfering with the vessel's design and construction. This notification of issuance of a certificate of alternative compliance promotes the Coast Guard's marine safety mission.
The Certificate of Alternative Compliance was issued on June 5, 2019.
For information or questions about this notice call or email LCDR Ronaydee M. Marquez, District Five, Asst. Chief, Inspections and Investigations, U.S. Coast Guard; telephone: 757-398-6682, email:
The United States is signatory to the International Maritime Organization's International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The special construction or purpose of some vessels makes them unable to comply with the light, shape, or sound signal provisions of the 72 COLREGS. Under statutory law, however, specified 72 COLREGS provisions are not applicable to a vessel of special construction or purpose if the Coast Guard determines that the vessel cannot comply fully with those requirements without interfering with the special function of the vessel.
The owner, builder, operator, or agent of a special construction or purpose vessel may apply to the Coast Guard District Office in which the vessel is being built or operated for a determination that compliance with alternative requirements is justified,
The Fifth District, Chief of Prevention Division, U.S. Coast Guard, certifies that the CAPE HATTERAS, O.N. 1293071 is a vessel of special construction or purpose, and that, with respect to the position of the sidelights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, or design of the vessel. The vessel is a dual-mode Articulated Tug (ATB), which intends to operate as an ATB as well as multiple other modes such as towing alongside, harbor ship/barge assist tug and towing on a towline. Placing the sidelights at or near the side of the vessel would interfere with the vessel's purpose and operations, and would place the sidelights at risk of damage during the course of normal operations. The sidelights will be
This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.
Federal Emergency Management Agency; DHS.
Notice; correction.
On May 20, 2019, FEMA published in the
Comments are to be submitted on or before September 9, 2019.
The Preliminary Flood Insurance Rate Map (FIRM), and where applicable, the Flood Insurance Study (FIS) report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1927, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed in the table below, in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP may only be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The communities affected by the flood hazard determinations are provided in the table below. Any request for reconsideration of the revised flood hazard determinations shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations will also be considered before the FIRM and FIS report are made final.
In the proposed flood hazard determination notice published at 84 FR 22875-22876 in the May 20, 2019, issue of the
In this document, FEMA is publishing a table containing the accurate information. The information provided below should be used in lieu of that previously published.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before September 9, 2019.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1936, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Fish and Wildlife Service, Interior.
Notice of initiation of reviews; request for information.
We, the U.S. Fish and Wildlife Service (Service), are initiating 5-year status reviews for 91 species in Oregon, Washington, Hawaii, and American Samoa under the Endangered Species Act of 1973. Three of these species also occur outside U.S. jurisdiction in Canada and the South Pacific. A 5-year review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any new information on these species that has become available since the last review.
To ensure consideration in our reviews, we are requesting submission of new information no later than August 12, 2019. However, we will continue to accept new information about any species at any time.
Submit information on the streaked horned lark via U.S. mail to Field Supervisor, Attention: 5-Year Review, U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office, 2600 SE 98th Ave., Suite 100, Portland, OR 97266.
Submit information on the pocket gophers, Oregon spotted frog, Taylor's checkerspot butterfly, Umtanum Desert buckwheat, and White Bluffs bladderpod via U.S. mail to Field Supervisor, Attention: 5-Year Review, U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office, 510 Desmond Dr. Southeast, Suite 102, Lacey, WA 98503.
Submit information on any of the 82 Pacific Islands species (occurring in Hawaii, American Samoa, Samoa, Fiji, Tonga, and Vanuatu) via U.S. mail to Field Supervisor, Attention: 5-Year Review, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Blvd., Room 3-122, Honolulu, HI 96850; or by email to
For the streaked horned lark, contact Michele Zwartjes, U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office, at 503-231-6179.
For the pocket gophers, Oregon spotted frog, Taylor's checkerspot butterfly, Umtanum Desert buckwheat, and White Bluffs bladderpod, contact Tom McDowell, U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office, at 360-753-9440.
For the 82 Pacific Islands species, contact Gregory Koob, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, at 808-792-9400.
Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at 800-877-8339 for TTY assistance.
Under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531
A 5-year review considers all new information available at the time of the review. In conducting these reviews, we consider the best scientific and commercial data that have become available since the listing determination or most recent status review, such as:
(A) Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;
(B) Habitat conditions, including but not limited to amount, distribution, and suitability;
(C) Conservation measures that have been implemented that benefit the species;
(D) Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the Act); and
(E) Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.
Any new information will be considered during the 5-year review and will also be useful in evaluating the ongoing recovery programs for these species.
This notice announces our active review of the 91 species listed in the table below.
To ensure that a 5-year review is complete and based on the best available scientific and commercial information, we request new information from all sources. See
If you wish to provide information for any species listed in the table, please submit your comments and materials to the appropriate contact in
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Comments and materials received will be available for public inspection, by appointment, during normal business hours at the offices to which the comments are submitted.
A list of all completed and currently active 5-year reviews addressing species for which the Pacific Region of the Service has lead responsibility is available at
This document is published under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before August 12, 2019.
Send your comments on this information collection request (ICR) to U.S. Geological Survey, Information Collections Officer, by email to
To request additional information about this ICR, contact Rudy Schuster by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection.
Interested persons are invited to submit comments on or before August 12, 2019.
Send your comments on this information collection request (ICR) by mail to the U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to
To request additional information about this ICR, contact Chris Schumacher by email [
In accordance with the Paperwork Reduction Act of 1995, we provide the public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The following information pertains to this request:
• 3604-1, Free Use Application and Permit for Mineral Materials; and
• 5510-1, Free Use Application and Permit for Vegetative Materials.
The estimated annual burdens of this collection are itemized below:
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before July 11, 2019.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Christian Schumacher by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
One addition, “Log Scale and Disposition of Timber Removed Report,” requires purchasers of Federal timber to report volumes of timber removed from Federal lands, and to identify processors of timber. Like the previously approved information collection activities, this activity assists
The other addition, “Protests,” provides an opportunity to seek administrative remedies for forest management decisions.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before May 25, 2019, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by June 26, 2019.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW, MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before May 25, 2019. Pursuant to Section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Nominations submitted by State Historic Preservation Officers:
An owner objection has been received for the following resource:
Additional documentation has been received for the following resources:
Section 60.13 of 36 CFR part 60.
National Park Service, Interior.
Request for nominations.
The National Park Service is soliciting nominations for two members of the Native American Graves Protection and Repatriation Review Committee. The Secretary of the Interior will appoint two members from nominations submitted by national museum organizations or national scientific organizations. The Review Committee was established by the Native American Graves Protection and Repatriation Act of 1990 (NAGPRA), and is regulated by the Federal Advisory Committee Act (FACA).
Nominations must be received by September 9, 2019.
Melanie O'Brien, Designated Federal Officer, Native American Graves Protection and Repatriation Review Committee, National NAGPRA Program (2253), National Park Service, 1849 C Street NW, Room 7360, Washington, DC 20240, (202) 354-2201 or via email
Melanie O'Brien, Designated Federal Officer, Native American Graves Protection and Repatriation Review Committee, National NAGPRA Program (2253), National Park Service, 1849 C Street NW, Room 7360, Washington, DC 20240, (202) 354-2201 or via email
The Review Committee is responsible for:
1. Monitoring the NAGPRA inventory and identification process;
2. Reviewing and making findings related to the identity or cultural affiliation of cultural items, or the return of such items;
3. Facilitating the resolution of disputes;
4. Compiling an inventory of culturally unidentifiable human remains and developing a process for disposition of such remains;
5. Consulting with Indian tribes and Native Hawaiian organizations and museums on matters within the scope of the work of the Review Committee affecting such tribes or organizations;
6. Consulting with the Secretary of the Interior in the development of regulations to carry out NAGPRA; and
7. Making recommendations regarding future care of repatriated cultural items.
The Review Committee consists of seven members appointed by the Secretary of the Interior. The Secretary may not appoint Federal officers or employees to the Review Committee. Three members are appointed from nominations submitted by Indian tribes, Native Hawaiian organizations, and traditional Native American religious leaders. At least two of these members must be traditional Indian religious leaders. Three members are appointed from nominations submitted by national museum or scientific organizations. One member is appointed from a list of persons developed and consented to by all of the other members.
Members serve as special Government employees, and are required to complete ethics training and file a confidential financial disclosure form on an annual basis. Members are appointed for 4-year terms and incumbent members may be reappointed for 2-year terms. The Review Committee's work is completed during public meetings. The Review Committee attempts to meet in person twice a year and meetings normally last two or three days. In addition, the Review Committee may also meet by public teleconference one or more times per year.
Review Committee members serve without pay but are reimbursed for each day of meeting attendance. Review Committee members are also reimbursed for travel expenses incurred in association with Review Committee meetings (25 U.S.C. 3006(b)(4)). Additional information regarding the Review Committee, including the Review Committee's charter, meeting protocol, and dispute resolution procedures, is available on the National NAGPRA Program website, at
Nominations must:
1. Be submitted by a national museum organization or national scientific organization and should be submitted on the official letterhead of the organization.
2. Affirm that the signatory is the official authorized by the organization to submit the nomination.
3. Affirm that the organization's activity pertains or relates to the United States as a whole, as opposed to a lesser geographical scope.
4. Provide the nominator's original signature, daytime telephone number, and email address.
5. Include the nominee's full legal name, home address, home telephone number, and email address.
Nominations should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Committee and permit the Department of the Interior to contact a potential member.
5 U.S.C. Appendix 2; 25 U.S.C. 3006.
United States International Trade Commission.
Notice of institution of investigation and scheduling of public hearing.
Following receipt of a request on June 4, 2019, from the United States Trade Representative (USTR), the U.S. International Trade Commission (Commission) instituted investigation No. 332-572,
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW, Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Information specific to this investigation may be obtained from Mark Brininstool, Project Leader, Office of Industries (202-708-1395 or
The Commission may include some or all of the confidential business information submitted in the course of this investigation in the report it sends to the USTR. Additionally, all information, including confidential business information, submitted in this
By order of the Commission.
Federal Bureau of Investigation, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
The Department of Justice encourages public comment and will accept input until August 12, 2019.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated burden and associated response time, should be directed to Mrs. Amy C. Blasher, Unit Chief, Federal Bureau of Investigation, Criminal Justice Information Services Division, Module E-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Department of Justice Desk Officer, Washington, DC 20503 or send to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
On June 5, 2019, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Eastern District of Pennsylvania in the lawsuit entitled
In its Complaint, pursuant to Section 107(a) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (“CERCLA”), 42 U.S.C. 9607(a), the United States alleges that the City, as an owner, arranger, and transporter, and the Philadelphia Redevelopment Authority, as an owner and operator, are liable for a portion of the cleanup costs incurred and to be incurred by the Environmental Protection Agency in connection with the cleanup of Operable Unit 1 (“OU 1”) of Lower Darby Creek Area Superfund Site (a.k.a. the “Clearview Landfill”). The Site is located on the east side of Darby Creek near the intersection of 84th Street and Lindbergh Boulevard in Delaware County and Philadelphia County, Pennsylvania.
The proposed Consent Decree resolves all allegations asserted in the United States' Complaint and provides for a combined payment of $8.4 million (City, $6,540,000; Redevelopment Authority, $1,863,000) in four installment payments, between 2019 and 2022. In exchange, the City and Redevelopment Authority receive from the United States a covenant not to sue for past and future response costs for OU 1, subject to certain reservations and limitations. The United States, which the City and Redevelopment Authority allege is also a responsible party at OU 1, also receives a qualified release for OU 1 from the City and Redevelopment Authority.
The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $ 10.75 (0.25 cents per page reproduction cost) payable to the United States Treasury for a copy of the Consent Decree with appendices. For a paper copy without the appendices, the cost is $ 9.25.
U.S. Marshals Service, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), U.S. Marshals Service (USMS), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until July 11, 2019.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Nicole Timmons either by mail at CG-3, 10th Floor, Washington, DC 20530-0001, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
11:00 a.m. to 4:30 p.m., Wednesday, June 26, 2019; 1:00 p.m. to 4:30 p.m., Thursday, June 27, 2019; and 9:00 a.m. to 12:00 p.m., Friday, June 28, 2019.
The offices of the Morris K. Udall and Stewart L. Udall Foundation, 130 South Scott Avenue, Tucson, AZ 85701.
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
(1) Call to Order and vote to go into Executive Sessions for matters (2), (3), and (4); (2) Discuss internal personnel rules and practices of the Morris K. Udall and Stewart L. Udall Foundation as regards the Executive Director search procedures; (3) Interview the finalist candidates for the position of Executive Director of the Morris K. Udall and Stewart L. Udall Foundation; (4) Discuss and determine the Board's decision for action on the Executive Director selection for the Morris K. Udall and Stewart L. Udall Foundation; and (5) Review and vote on a Consent Agenda for regular business of the Board of Trustees (Minutes of the December 11, 2018, Board of Trustees Meeting; Board Reports submitted for Education Programs, Finance and Management, Udall Center for Studies in Public Policy-Native Nations Institute-Udall Archives, and U.S. Institute for Environmental Conflict Resolution; and Board takes notice of any new and updated personnel policies).
All agenda items except as noted below.
Executive Sessions to Discuss internal personnel rules and practices of the Morris K. Udall and Stewart L. Udall Foundation as regards the Executive Director search procedures; Interview the finalist candidates for the position of Executive Director of the Morris K. Udall and Stewart L. Udall Foundation; and Discuss and determine the Board's decision for action on the Executive Director selection for the Morris K. Udall and Stewart L. Udall Foundation.
Marc J. Rosen, Acting Executive Director and General Counsel, 130 South Scott Avenue, Tucson, AZ 85701, (520) 901-8500.
National Science Foundation.
Submission for OMB Review; Comment Request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the
To be sure your comments regarding this information collection are fully considered, NSF needs to receive them by July 11, 2019.
Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 17th Street NW Room 10235, Washington, DC 20503, and Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to
Copies of the submission may be obtained by calling 703-292-7556.
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Comments regarding (a) whether the 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 including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the
National Science Foundation.
Submission for OMB review; comment request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the
Comments regarding this information collection are best assured of having their full effect if received by July 11, 2019.
Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 17th Street NW, Room 10235, Washington, DC 20503, and Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to
Copies of the submission may be obtained by calling 703-292-7556.
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Comments regarding (a) whether the 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 including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to the points of contact in the
The draft Major Facilities Guide and Financial Data Collection Tool for Major Facilities were made available for review by the public on the NSF website at
• 48 requested further guidance on project management controls and NSF oversight processes and procedures for major facilities and mid-scale projects;
• 20 requested clarification on the processes and requirements associated with cost and contingency through the various stage of the facility lifecycle;
• 24 requested clarification on the guidance for cybersecurity programs for major facilities;
• 6 requested clarifications on guidance for mid-scale projects;
• 8 requested clarifications of requirements during the various stages of the facility lifecycle;
• 8 provided general observations; and
• 22 provided editing recommendations such as typos and sentence structure.
The full comments and NSF's response may be found via:
“To promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense. * * *”
The Act authorized and directed NSF to initiate and support:
• Basic scientific research and research fundamental to the engineering process;
• Programs to strengthen scientific and engineering research potential;
• Science and engineering education programs at all levels and in all the various fields of science and engineering;
• Programs that provide a source of information for policy formulation; and
• Other activities to promote these ends.
Among Federal agencies, NSF is a leader in providing the academic community with advanced instrumentation needed to conduct state-of-the-art research and to educate the next generation of scientists, engineers and technical workers. The knowledge generated by these tools sustains U.S. leadership in science and engineering (S&E) to drive the U.S. economy and secure the future. NSF's responsibility is to ensure that the research and education communities have access to these resources, and to provide the support needed to utilize them optimally and implement timely upgrades.
The scale of advanced instrumentation ranges from small research instruments to shared resources or facilities that can be used by entire communities. The demand for such instrumentation is very high, and is growing rapidly, along with the pace of discovery. For major facilities and shared infrastructure, the need is particularly high. This trend is expected to accelerate in the future as increasing numbers of researchers and educators rely on such major facilities, instruments, and databases to provide the reach to make the next intellectual leaps.
NSF currently provides support for facility construction from two accounts: The Major Research Equipment and Facility Construction (MREFC) account, and the Research and Related Activities (R&RA) account. The MREFC account, established in FY 1995, is a separate budget line item that provides an agency-wide mechanism, permitting directorates to undertake major facility projects are roughly $70M or greater. Smaller projects continue to be supported from the R&RA Account.
Facilities are defined as shared-use infrastructure, instrumentation and equipment that are accessible to a broad community of researchers and/or educators. Facilities may be centralized or may consist of distributed installations. They may incorporate large-scale networking or computational infrastructure, multi-user instruments or networks of such instruments, or other infrastructure, instrumentation and equipment having a major impact on a broad segment of a scientific or engineering discipline. Historically, awards have been made for such diverse projects as accelerators, telescopes, research vessels and aircraft, and geographically distributed but networked sensors and instrumentation.
The growth and diversification of major facility projects require that NSF remain attentive to the ever-changing issues and challenges inherent in their planning, construction, operation, management and oversight. Most importantly, dedicated, competent NSF and awardee staff are needed to manage and oversee these projects; giving the attention and oversight that good practice dictates and that proper accountability to taxpayers and Congress demands. To this end, there is also a need for consistent, documented requirements and procedures to be understood and used by NSF program managers and awardees for all such major projects.
• Provide step-by-step guidance for NSF staff and awardees to carry out effective project planning, management and oversight of major facilities while considering the varying requirements of a diverse portfolio;
• Clearly state the policies, processes and procedures pertinent at each stage of a facility's life cycle from development through construction, operations, and termination; and
• Document and disseminate “good practices” identified over time so that NSF and awardees can carry out their responsibilities more effectively.
This version of the Major Facilities Guide (previously referred to as the
This Guide will be updated periodically to reflect changes in requirements, policies and/or procedures. Award Recipients are expected to monitor and adopt the requirements and best practices included in the Guide which are aimed at improving management and oversight of major facilities projects and at enabling the most efficient and cost-effective delivery of tools to the research and education communities.
The submission of proposals and subsequent project documentation to the Foundation related to the development, construction and operations of Major Facilities is part of the collection of information. This information is used to help NSF fulfill this responsibility in supporting merit-based research and education projects in all the scientific and engineering disciplines. The Foundation also has a continuing commitment to provide oversight on facilities development and construction which must be balanced against monitoring its information collection so as to identify and address any excessive reporting burdens.
NSF has approximately twenty-four (24) Major Facilities in various stages of
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 5, 2019, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 4, 2019, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on June 5, 2019, it filed with the Postal Regulatory Commission a
On April 5, 2019, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change would revise the ICC Model Validation Framework (“Framework”), which sets forth ICC's model validation procedures.
The proposed rule change would update the Framework's classification of Model Components, categorization of model changes, documentation requirements relating to model inventory, the priority scale used by independent validators, and the annual validation of Model Components and related practices.
The proposed rule change would revise the `Risk Management System Models' section to account for Model Components that are no longer utilized.
In the `Model Change Qualification and Materiality' section, the proposed rule change would add a quantitative measure to define certain Model Changes.
The proposed revisions to the `Documentation Requirements' section of the Framework would relate to the Model Inventory.
The proposed updates to the `Independent Initial Validation' section would relate to the priority scale used by independent validators in completing initial validations.
The proposed rule change would make clarifying changes to the `Independent Periodic Review' section.
Section 19(b)(2)(C) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to such organization.
Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of ICC be designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions, as well as to assure the safeguarding of securities and funds which are in the custody or control of ICC or for which it is responsible, and, in general, to protect investors and the public interest.
The Commission believes that the proposed rule change would enhance the operation of the Framework. Specifically, the Commission believes that in adding a category for retired Model Components the proposed rule change would distinguish Model Components that are no longer used, avoiding potential confusion regarding which Model Components are currently effective.
The Commission also believes that by adding a quantitative measure to define Materiality A Model Changes, the proposed rule change would provide greater certainty and objectivity regarding Materiality A Model Changes, which is important given that Materiality A Model Changes are subject to internal initial validation and an independent initial validation.
The Commission further believes that in adding retired Model Components to the Model Inventory the proposed rule change would help ensure that ICC has information on retired Model Components in case it ever needs to employ those Model Components again or needs to use those retired Model Components in developing new Model Components. Moreover, the Commission believes that in removing information no longer considered relevant to the Model Inventory, the proposed rule change would help to ensure that the Model Inventory focuses only on the information needed to carry out the purposes of the Framework.
In specifying that ICC, in consultation with the Risk Committee, may determine that a low priority item found by an independent validator during an initial validation or periodic review does not reflect a potential deficiency and take no action in response to the item, the Commission believes that the proposed rule change would allow ICC to efficiently close findings by independent validators that may have no material impact on ICC's risk management system. Doing so could also free up resources within ICC and the Risk Committee to respond to other, higher priority findings by independent validators.
Finally, by specifying that independent validators perform periodic reviews of Model Components and related practices at least every twelve months and that ICC relies on the date of the engagement letter to track this twelve month requirement, the Commission believes that the proposed rule change would help to ensure that all Model Components and related practices are reviewed annually by providing a uniform and objective means of tracking the date of the validation through the date of the engagement letter.
For these reasons, the Commission believes these proposed revisions to the Framework would help improve the functioning of the Framework. The Commission further believes that because the Framework allows ICC to determine the appropriateness of Model Change and Model Components, a well-functioning Framework is necessary for an effective risk management system. Moreover, the Commission believes that ICC's risk mismanagement system enables ICC to manage the risks associated with clearing security based swap-related portfolios, and that such risks, if not properly managed, could cause ICC to realize losses on such portfolios and disrupt ICC's ability to promptly and accurately clear security based swap transactions. The Commission therefore believes that the proposed rule change, in improving the Framework and thereby improving the functioning of ICC's risk management system, would promote the prompt and accurate clearance and settlement of securities transactions. Similarly, given that mismanagement of the risks associated with clearing security based swap-related portfolios could cause ICC to realize losses on such portfolios and threaten ICC's ability to operate, thereby threatening access to securities and funds in ICC's control, the Commission believes that the proposed rule change, in improving the Framework, would help assure the safeguarding of securities and funds which are in the custody or control of the ICC or for which it is responsible. Finally, for both
Therefore, the Commission finds that the proposed rule change would promote the prompt and accurate clearance and settlement of securities transactions, assure the safeguarding of securities and funds in ICC's custody and control, and, in general, protect investors and the public interest, consistent with the Section 17A(b)(3)(F) of the Act.
Rule 17Ad-22(b)(2) requires that ICC establish, implement, maintain and enforce written policies and procedures reasonably designed to use margin requirements to limit its credit exposures to participants under normal market conditions and use risk-based models and parameters to set margin requirements and review such margin requirements and the related risk-based models and parameters at least monthly.
As described above, the proposed rule change would enhance the operation of the Framework. In doing so, the Commission believes that the proposed rule change would help ensure that ICC's risk management system is appropriate and effective for dealing with the risks associated with clearing security based swap-related portfolios. The Commission further believes that the proposed improvements to the Framework would also improve ICC's review and maintenance of the models that generate margin requirements. The Commission believes that the proposed rule change would therefore improve ICC's use of initial margin requirements to limit its credit exposures to participants under normal market conditions and ICC's use of risk-based models and parameters to set margin requirements. The Commission therefore finds that the proposed rule change is consistent with Rule 17Ad-22(b)(2).
Moreover, the amount a clearing member must contribute to ICC's Guaranty Fund is equal to the expected losses to ICC associated with the default of that clearing member, calculated using ICC's stress test methodology, and taking into account, among other things, the loss after application of initial margin.
Therefore, for the above reasons the Commission finds that the proposed rule change is consistent with Rules 17Ad-22(b)(2) and 17Ad-22(b)(3).
Rule 17Ad-22(b)(4) requires that ICC establish, implement, maintain and enforce written policies and procedures reasonably designed to provide for an annual model validation consisting of evaluating the performance of its margin models and the related parameters and assumptions associated with such models by a qualified person who is free from influence from the persons responsible for the development or operation of the models being validated.
As discussed above, the proposed rule change would revise the Framework to specify that independent validators perform periodic reviews of Model Components and related practices at least every twelve months and that ICC relies on the date of the engagement letter to track this twelve month requirement. The Commission believes that the proposed rule change would therefore help to ensure that all Model Components and related practices are reviewed annually by providing a uniform and objective means of tracking the date of the validation through the date of the engagement letter. Therefore, the Commission finds that the proposed rule change is consistent with Rule 17Ad-22(b)(4).
On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act, and in particular, with the requirements of Section 17A(b)(3)(F) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) proposes to adopt limit-on-close (“LOC”) and market-on-close (“MOC”) orders. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In 2016, the Exchange's parent company, Cboe Global Markets, Inc. (“Cboe Global”), also the parent company of Cboe Exchange, Inc. (“Cboe Options”), acquired Cboe EDGX Exchange, Inc. (“EDGX or EDGX Options”), Cboe EDGA Exchange, Inc. (“EDGA”), Cboe BZX Exchange, Inc. (“BZX or BZX Options”), and Cboe BYX Exchange, Inc. (“BYX” and, together with Cboe Options, the Exchange, EDGX, EDGA, and BZX, the “Cboe Affiliated Exchanges”). The Cboe Affiliated Exchanges are working to align certain system functionality, retaining only intended differences between the Cboe Affiliated Exchanges, in the context of a technology migration. Cboe Options intends to migrate its technology to the same trading platform used by the Exchange, EDGX Options, and BZX Options in the fourth quarter of 2019. The proposal set forth below is intended to add certain functionality to the Exchange's System that is available on Cboe Options in order to ultimately provide a consistent technology offering for market participants who interact with the Cboe Affiliated Exchanges.
The Exchange proposes to adopt LOC and MOC orders. The proposed amendments to Rule 6.10(d) define an LOC order as a limit order, and an MOC order as a market order, respectively, that may only execute on the Exchange no earlier than three minutes prior to Regular Trading Hours (“RTH”) market close. The System enters LOC and MOC orders into the Book in time sequence (based on the times at which the Exchange initially received them), where they may be processed in accordance with Rule 6.12.
The Exchange also proposes to add subparagraph (C) to Rule 6.12(c)(5) to include additional order handling regarding MOC orders during a limit up-limit down state.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed adoption of MOC and LOC orders serves to benefit investors by allowing Users flexibility to have orders only be eligible for execution near the close, a time in which maximum significant number of participants interact on the Exchange. The Exchange believes that the proposed change promotes just and equitable principles of trade because it encourages increased participation near the close, thereby contributing to enhanced price discovery and transparency that will result in a closing price point that more closely reflects the interest of market participants. The Exchange also believes that the proposed change will benefit investors by fostering increased liquidity near the close. As stated, the proposed change is based on Cboe Options rules.
Furthermore, the Exchange believes specifying that the MOC and LOC may execute no more than three minutes from the RTH close removes impediments to and perfects the mechanism of a free and open market and national market system and protects investors because it will allow Users greater flexibility regarding the execution of their orders and/or their customers' orders. The Exchange believes this three minute time-frame prior to the RTH market close is a reasonable time prior to the market close to trigger MOC and LOC orders, because it provides those orders with sufficient times to interact with contra-side interest and to potentially execute at a time close to RTH market close.
The Exchange also believes not permitting bulk messages to be MOC and LOC orders will remove impediments to and perfect the mechanism of a free and open market and protect investors because it is consistent with the purpose of bulk messages. As stated, bulk messages are currently restricted to designation as time-in-force of Day in order to encourage Users to provide liquidity to the Exchange's market during RTH and update bulk messages in response to day-to-day changed market conditions.
Moreover, the Exchange also believes that rejecting MOC and LOC orders if designated as “All Sessions” serves to remove impediments to and perfect the mechanism of a free and open market and protect investors by providing functionality that is consistent with the purpose of MOC and LOC orders. As described above, because MOC and LOC orders are linked to the RTH close, allowing MOC or LOC orders to be marked for All Sessions (
Additionally, the Exchange believes that the proposed additional order handling for MOC during a limit up-limit down state protects investors because it is consistent with the Limit Up-Limit Down Plan and prevents a market order from executing outside of the specified price bands. This order handling is consistent with that of Cboe Options rules.
Lastly, the Exchange notes that the proposed rule change is generally intended to align the functionality offered by the Exchange with functionality currently offered by Cboe Options in order to provide a consistent technology offering for the Cboe Affiliated Exchanges.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition, as the proposed rule change will apply in the same manner to all orders submitted as MOC or as LOC. MOC and LOC orders will be available to all Users, and MOC and LOC orders from all Users will be handled in the same manner. The use of
The Exchange neither solicited nor received comments on the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Exchange has asked the Commission to waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest as it will allow the Exchange to offer two order types that are substantially similar to order types that are currently available on Cboe Options. Thus, as represented by the Exchange, the proposed rule change does not introduce any new functionality or present any novel issues. For this reason, the Commission designates the proposed rule change to be operative on June 20, 2019, the day before the Exchange would like to implement MOC and LOC orders.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On November 29, 2018, The Depository Trust Company (“DTC”), filed with the Securities and Exchange Commission (“Commission”) a proposed rule change, pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change was published for comment in the
Section 19(b)(2)(B)(ii) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the comment letters. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend BOX Rule IM-5050-1 (Strike Price Intervals) to allow for $1 strike prices above $200 on additional options on Units of certain exchange-traded fund (“ETF”) products. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend BOX Rule IM-5050-1 to allow for $1 strike prices above $200 on additional options on Units of certain exchange-traded fund (“ETF”) products. This is a competitive filing that is based on a proposal recently submitted by Cboe Exchange, Inc. (“Cboe”) and approved by the Commission.
Currently, IM-5050-1(b) to Rule 5050 allows for the interval between strike prices of series of options on Units of SPY, IVV, and DIA to be $1 or greater where the strike price is greater than $200. Under IM-5050-1(b), for all other series of options on Exchange Traded Fund Shares that satisfy the criteria set forth in Rule 5020(h), the interval of strike prices may be $1 or greater where the strike price is $200 or less or $5 or greater where the strike price is over $200. The Exchange now proposes to modify the interval setting regime to allow $1 strike price intervals where the strike price is above $200 for IWM and QQQ options. The Exchange believes that the proposed rule change would make QQQ and IWM options easier for investors and traders to use and more tailored to their investment needs.
The QQQ and IWM are designed to provide investors different ways to efficiently gain exposure to the equity markets and execute risk management, hedging, asset allocation and income generation strategies. The QQQ is a Unit investment trust designed to closely track the price and performance of a the Nasdaq-100 Index (“NDX”), which represents the largest and most active non-financial domestic and international issues listed on The Nasdaq Stock Market based on market capitalization. Likewise, the IWM is an index ETF designed to closely track the price and performance of the Russell 2000 Index (“RUT”), which represents the small capitalization sector of the U.S. equity market. In general, QQQ and
The value of QQQ is designed to approximate 1/40 the value of the underlying NDX. For example, if the NDX price level is 1400, QQQ strike prices generally would be expected to be priced around $35. The value of IWM is designed to approximate 1/10 the value of the underlying RUT. In the past year, the NDX has climbed above a price level of 7500, and the RUT climbed to a price level of approximately 1700 (both prior to the December 2018 market-wide decline). As the value of the underlying ETF (and the index the ETF tracks) and resulting strike prices for each option continues to appreciate, market participants have requested the listing of additional strike prices ($1 increments) in QQQ and IWM options above $200. The QQQ is among the most actively traded ETFs on the market. It is widely quoted as an indicator of technology stock prices and investor confidence in the technology and telecommunication market spaces, a significant indicator of overall economic health. Similarly, IWM is among the most actively traded ETFs on the market and provides investors with an investment tool to gain exposure to small U.S. public companies. Industry-wide trade volume in QQQ more than doubled from 2017 to 2018. As a result, QQQ options and IWM options have grown to become two of the largest options contracts in terms of trading volume. Investors use these products to diversify their portfolios and benefit from market trends.
Accordingly, the Exchange believes that offering a wider base of QQQ and IWM options affords traders and investors important hedging and trading opportunities, particularly in the midst of current price trends. The Exchange believes that not having the proposed $1 strike price intervals above $200 in QQQ and IWM significantly constricts investors' hedging and trading possibilities. The Exchange therefore believes that by having smaller strike intervals in QQQ and IWM, investors would have more efficient hedging and trading opportunities due to the lower $1 interval ascension. The proposed $1 intervals above the $200 strike price will result in having at-the-money series based upon the underlying ETFs moving less than 1%. The Exchange believes that the proposed strike setting regime is in line with the slower movements of broad-based indices. Considering the fact that $1 intervals already exist below the $200 price point and that both QQQ and IWM have consistently inclined in price toward the $200 level, the Exchange believes that continuing to maintain the current $200 level (above which intervals increase 500% to $5), may have a negative effect on investing, trading and hedging opportunities, and volume. The Exchange believes that the investing, trading, and hedging opportunities available with QQQ and IWM options far outweighs any potential negative impact of allowing QQQ and IWM options to trade in more finely tailored intervals above the $200 price point.
The proposed strike setting regime would permit strikes to be set to more closely reflect the increasing values in the underlying indices and allow investors and traders to roll open positions from a lower strike to a higher strike in conjunction with the price movements of the underlying ETFs. Under the current rule, where the next higher available series would be $5 away above a $200 strike price, the ability to roll such positions is effectively negated. Accordingly, to move a position from a $200 strike to a $205 strike under the current rule, an investor would need for the underlying product to move 2.5%, and would not be able to execute a roll up until such a large movement occurred. As stated, the NDX and RUT have experienced continued, steady growth. The Exchange believes that with the proposed rule change, the investor would be in a significantly safer position of being able to roll his open options position from a $200 to a $201 strike price, which is only a 0.5% move for the underlying. As a result, the proposed rule change will allow the Exchange to better respond to customer demand for QQQ and IWM strike prices more precisely aligned with the smaller, longer-term incremental increases in respective underlying ETFs. The Exchange believes that the proposed rule change, like the other strike price programs currently offered by the Exchange, will benefit investors by providing investors the flexibility to more closely tailor their investment and hedging decisions using QQQ and IWM options. Moreover, by allowing series of QQQ and IWM options to be listed in $1 intervals between strike prices over $200, the proposal will moderately augment the potential total number of options series available on the Exchange. However, the Exchange believes it and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange also believes that Participants will not have a capacity issue due to the proposed rule change. In addition, the Exchange represents that it does not believe that this expansion will cause fragmentation of liquidity, but rather, believes that finer strike intervals will serve to increase liquidity available as well as price efficiency by providing more trading opportunities for all market participants.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
In particular, the proposed rule change to IM-5050-1(b) will allow investors to more easily use QQQ and IWM options. Moreover, the proposed rule change would allow investors to better trade and hedge positions in QQQ and IWM options where the strike price is greater than $200, and ensure that investors in both options are not at a disadvantage simply because of the strike price.
The Exchange believes the proposed rule change is consistent with Section 6(b)(1) of the Act, which provides that the Exchange be organized and have the capacity to be able to carry out the purposes of the Act and the rules and regulations thereunder, and the rules of the Exchange. The rule change proposal allows the Exchange to respond to customer demand to allow QQQ and IWM options to trade in $1 intervals above a $200 strike price. The Exchange does not believe that the proposed rule would create additional capacity issues or affect market functionality.
As noted above, ETF options trade in wider $5 intervals above a $200 strike price, whereby options at or below a $200 strike price trade in $1 intervals. This creates a situation where contracts on the same option class effectively may not be able to execute certain strategies such as, for example, rolling to a higher strike price, simply because of the $200 strike price above which options intervals increase by 500%. This proposal remedies the situation by
The Exchange believes that the proposed rule change, like other strike price programs currently offered by the Exchange, will benefit investors by giving them increased flexibility to more closely tailor their investment and hedging decisions. Moreover, the proposed rule change is consistent with changes adopted by Cboe.
With regard to the impact of this proposal on system capacity, the Exchange believes it and OPRA have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange believes that its Participants will not have a capacity issue as a result of this proposal.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Rather, the Exchange believes that the proposed rule change will result in additional investment options and opportunities to achieve the investment and trading objectives of market participants seeking efficient trading and hedging vehicles, to the benefit of investors, market participants, and the marketplace in general. Specifically, the Exchange believes that QQQ and IWM options investors and traders will significantly benefit from the availability of finer strike price intervals above a $200 price point. In addition, the interval setting regime the Exchange proposes to apply to QQQ and IWM options is currently applied to SPY, IVV, and DIA options, which are similarly popular and widely traded ETF products and track indexes at similarly high price levels. Thus, the proposed strike setting regime for QQQ and IWM options will allow options on the most actively traded ETFs with index levels at corresponding price levels to trade pursuant to the same strike setting regime. This will permit investors to employ similar investment and hedging strategies for each of these options.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The principal purpose of the proposed rule change is to revise the ICC Risk Management Model Description. These revisions do not require any changes to the ICC Clearing Rules (“Rules”).
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change, security-based swap submission, or advance notice and discussed any comments it received on the proposed rule change, security-based swap submission, or advance notice. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
ICC proposes to revise its Risk Management Model Description. Specifically, ICC proposes minor, clarifying changes to address comments received from an independent validation, as well as additional clean-up changes. The independent validator comments revolve around clarification updates that do not change ICC's current risk methodology. ICC believes that such revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. The proposed changes are described in detail as follows.
ICC proposes minor changes to the `Initial Margin Methodology' section to maintain uniformity and provide additional clarity in the Risk Management Model Description. ICC proposes to update a symbol representing the portfolio level liquidity charge (“LC”) in an equation in the `Portfolio Level LC' sub-section to match the symbol used throughout the document to reference the portfolio level LC. Moreover, the Risk Management Model Description numbers key equations so they can be easily referenced. As such, ICC proposes to include a number corresponding to the equation for the portfolio level LC and to re-number the equations that follow accordingly. In the `Portfolio Level Concentration Charge' sub-section, ICC proposes to correct a typographical error when referencing the portfolio level concentration charge (“CC”); to update a symbol representing the portfolio level CC in an equation to match the symbol used throughout the document to reference the portfolio level CC; and to include a number corresponding to the equation for the portfolio level CC, re-numbering the equations that follow accordingly. Additionally, ICC proposes to update a symbol representing the portfolio level interest rate (“IR”) sensitivity requirement in an equation in the `IR Sensitivity Risk Analysis' sub-section to match the symbol used throughout the document to refer to the portfolio level IR sensitivity requirement. ICC further proposes updates to the `Portfolio Loss Boundary Condition' sub-section to replace certain general references to sections with more specific references to equations in those sections to provide for additional clarity.
ICC proposes to make such changes effective shortly after filing with the Commission, on or about May 31, 2019.
Section 17A(b)(3)(F) of the Act
In addition, the proposed rule change is consistent with the relevant requirements of Rule 17Ad-22.
Rule 17Ad-22(b)(3)
Rule 17Ad-22(d)(8)
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The proposed changes to ICC's Risk Management Model Description will apply uniformly across all market participants. Therefore, ICC does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2019-006 and
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) proposes to update its Price Adjust process to allow for the process to apply to bulk messages. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its rules to allow for the Price Adjust process to apply to bulk messages and make corresponding changes where applicable. The Exchange is proposing these amendments in order to provide Options Members that submit bulk messages with functionality that is currently available to them for orders.
In February 2019, the Exchange adopted bulk messaging functionality, in which a User may enter, modify or cancel up to an Exchange-specified number of bids and offers. A User may submit a bulk message through a bulk port.
Current Rule 6.10(c) also provides for a Cancel Back order, in which a User may designate an order not to be subject to the Price Adjust process and the System cancels or rejects such order if displaying the order on the C2 Book would create a violation of Rule 6.82 (Locked and Crossed Markets), or if the order cannot otherwise be executed or displayed in the C2 Book at its limit price. The System executes a Book Only—Cancel Back order marketable against resting orders, and cancels or rejects a Post Only—Cancel Back order that locks or crosses the opposite side of the BBO.
Furthermore, current Rule 6.12(c) provides for additional System order handling provisions regarding bulk messages submitted through bulk quoting ports. Specifically, Rule 6.12(c)(6)(A) provides that the System will cancel or reject a Post Only bulk message bid (offer) with a price that locks or crosses the Exchange best offer (bid) or ABO (ABB).
The Exchange now proposes to amend Rule 6.10(c) and Rule 6.12(b) to permit Users to designate bulk messages to be subject to the Price Adjust process, and permit Users to opt-out of such process for bulk messages by designating bulk messages as Cancel Back. The Price Adjust and Cancel Back designations, as applicable, will apply to all bulk message bids and offers within a single message. The Exchange notes that Users have noted the regularity with which their bulk messages are rejected because Price Adjust does not apply to them. As a result, some Users find this inefficient when submitting bulk messages. The Exchange believes that allowing bulk messages to be subject to the Price Adjust process will provide market participants with additional opportunities for execution and price improvement, as well as additional flexibility and control over their submission of bulk messages. If a User does not want a bulk message to be subject to the Price Adjust process, it may designate the bulk message as Cancel Back, as noted above. A Cancel Back bulk message will be handled in the same manner as a bulk message is handled today.
As proposed, all bulk messages would now be subject to the Price Adjust process if it locks or crosses the BBO or ABBO and rest in the C2 Book pursuant to the process, thus avoiding display of a locked or crossed market in accordance with the linkage rules.
The Exchange notes that allowing bulk messages to be subject to a repricing process is consistent with the handling of similar order (and quote) types on other exchanges.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed rule change subjecting bulk messages to the Price Adjust process will remove impediments to and perfect the mechanism of a free and open market because it provides Users with the flexibility to apply to bulk messages the same functionality they may apply to their orders. The Exchange believes that repricing bulk messages for Users (that do not opt out of the Price Adjust process), as opposed to automatically rejecting messages that lock or cross protected quotes when posted to the C2 Book, will permit Users to use bulk messages to respond to continuously changing market conditions in a more efficient manner, as well as provide additional opportunity for execution and price improvement. The proposed repricing of bulk messages prevents the display of a locked or crossed market and is consistent with the Linkage Plan,
The Exchange also believes that by providing Users with the ability to designate bulk messages as subject to the Price Adjust process instead of cancelling or rejecting these messages under certain circumstances, will give Users greater flexibility and control over the circumstances under which their orders are able to interact with contra side-interest on the Exchange. The Exchange believes this may increase the opportunities for execution at multiple price points and encourage the provision of more liquidity to the market, and therefore believes that it is reasonably designed to facilitate the mechanism of price discovery.
The Exchange notes that the options markets are quote driven markets and thus dependent on liquidity providers,
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, as the proposed application of the Price Adjust and the Cancel Back process to bulk messages will be available to all applicable Users (
The Exchange does not believe the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, because it will provide Users with bulk message repricing functionality that is similar to other order and quote repricing available on other options exchanges. The Exchange believes the proposed functionality will permit the Exchange to operate on an even playing field relative to other exchanges that have similar functionality.
As discussed above, the options markets are quote driven markets and thus dependent on various Users as liquidity providers and for price discovery. The Exchange believes the proposed amendment to subject bulk messages to the Price Adjust process will provide liquidity providers with additional flexibility and control over interactions of their bulk messages with contra-side liquidity, as well as additional opportunity for execution at multiple price points and price improvement. This may encourage the provision of more liquidity, which may result in more trading opportunities and tighter spreads, and contribute to price discovery. This may improve overall market quality and enhance competition on the Exchange, to the benefit of all investors.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) Impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to
You may submit comments by any of the following methods:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The information collected on the DS-5525, “Statement of Exigent/Special Family Circumstances for Issuance of a U.S. Passport to a Minor under Age 16”, is used in conjunction with the DS-11, “Application for a U.S. Passport”. The DS-5525 can serve as the statement describing exigent or special family circumstances, which is required if notarized written consent of the non-applying parent or guardian cannot be obtained when the passport application is executed for a minor under age 16.
Passport Services collects information from U.S. citizens and non-citizen nationals when they complete and submit the DS-5525, “Statement of Exigent/Special Family Circumstances for Issuance of a U.S. Passport to a Minor under Age 16”. Passport applicants can either download the DS-5525 from the internet or obtain the form from an Acceptance Facility/Passport Agency. The form must be completed, signed, and submitted along with the applicant's DS-11, “Application for a U.S. Passport”.
In a Notice of Proposed Rulemaking (NPR) served in this docket on February 4, 2013, the Board sought public comment on proposals to modify the Board's general purpose costing system, the Uniform Railroad Costing System (URCS), to eliminate a feature known as the “make-whole adjustment” and to adjust the locomotive unit-mile (LUM) cost allocation. After evaluating comments received in response to the NPR, the Board served a Supplemental Notice of Proposed Rulemaking (SNPR) on August 4, 2016, with modified proposals for eliminating the make-whole adjustment and changing the LUM cost allocation, and a new proposal to modify train-mile (TM) cost allocations. For the reasons stated below, the Board will discontinue this proceeding.
As discussed in prior decisions in this proceeding, the Board uses URCS for a variety of regulatory functions. URCS is used in rate reasonableness proceedings as part of the initial market dominance determination. URCS also plays a role in the Board's determination of whether a rate exceeds a reasonable maximum, and, when warranted, setting the maximum rate prescription. In addition, URCS is used to develop variable costs for making cost determinations in abandonment, certain trackage rights, and other proceedings; to provide the railroad industry and shippers with a standardized costing model; to cost the Board's Carload Waybill Sample; and to provide interested parties with basic cost information regarding railroad industry operations.
URCS develops a regulatory cost estimate that can be applied to a service that occurs anywhere on a rail carrier's system. These cost estimates are developed through three distinct phases of URCS.
• Phase I occurred only once when URCS was originally developed using the annual reports submitted by Class I rail carriers (R-1 reports). Regression
• Annually, in Phase II, URCS takes the aggregated cost data and traffic statistics provided by Class I carriers in their most recent R-1 reports and other reports and disaggregates them by calculating system-average unit costs associated with specific rail activities.
• In Phase III, when movements are costed, URCS takes the unit costs from Phase II and applies them to the characteristics of a particular movement in order to calculate the variable cost of that movement.
The Board initiated this proceeding to address concerns with the make-whole adjustment, which is calculated and applied in Phase III. The make-whole adjustment is intended to recognize the efficiency savings that a carrier obtains in its higher-volume shipments and thus render more appropriate unit costs. The Board questioned whether the current make-whole adjustment best reflects economies of scale as shipment size increases.
To address the concerns with the make-whole adjustment, the NPR proposed changes to switching costs related to switch engine minutes, equipment costs for the use of railroad-owned equipment during switching, station clerical costs, and car-mile costs, as well as other related changes to URCS.
After reviewing comments in response to the NPR, the Board modified its proposal in the SNPR by changing how the current efficiency adjustments would be applied to switching costs, railroad-owned equipment costs, station clerical costs, and car-mile costs.
The Board held a technical workshop regarding the SNPR proposals on September 7, 2016, and then received public comments on October 11, 2016, and reply comments on November 7, 2016.
The Board recognizes and appreciates the substantial effort undertaken by stakeholders in this proceeding to assist the Board in grappling with the complexities of URCS. The Board continues to believe that URCS can be updated to better reflect economies of scale and improve cost allocations. However, the Board has determined that potential refinements of URCS would benefit from additional study and analysis, as most commenters argued. Given the need for further study and analysis to arrive at a more optimal revision of the URCS system, and to also ensure efficient docket management, the Board will not take further action in this proceeding and will discontinue this docket. Any future proposals by the Board to update URCS would be made in a new proceeding.
1. This proceeding is discontinued.
2. Notice of the Board's action will be published in the
3. This decision is effective on its date of service.
By the Board, Board Members Begeman, Fuchs, and Oberman.
Tennessee Valley Authority (TVA).
Notice of meeting.
The TVA Regional Energy Resource Council (RERC) has scheduled a meeting to discuss the 2019 IRP development process, develop the RERC's 2019 IRP recommendation, and identify the challenges and opportunities faced by TVA in developing the 2019 IRP. The RERC was established to advise TVA on its energy resource activities and the priority to be placed among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA). Members of the TVA Board of Directors also plan to attend portions of this meeting.
The meeting will be held on Wednesday, June 26, 2019, from 12:45 p.m. to 6:00 p.m., EDT, and Thursday, June 27, 2019, from 8:30 a.m. to 2:30 p.m., EDT.
The meeting will be held at The Read House Hotel, 107 West MLK Boulevard, Chattanooga, Tennessee 37402. An Individual requiring special accommodation for a disability should let the contact below know at least a week in advance.
Liz Upchurch, 865-632-8305,
The meeting agenda includes the following:
The RERC, along with members of TVA's Board of Directors, will hear opinions and views of citizens during a public session starting at 5:00 p.m., EDT, lasting up to one hour, on
Tennessee Valley Authority.
30-Day notice of submission of information collection approval and request for comments.
This is a request for reinstatement of the Land Use Survey Questionnaire—Vicinity of Nuclear Power Plants (OMB No. 3316-0016) for which approval has expired. The information collection described below will be submitted to the Office of Management and Budget (OMB) at,
Comments should be sent to the TVA Senior Privacy Program Manager and the OMB Office of Information & Regulatory Affairs, Attention: Desk Officer for Tennessee Valley Authority, Washington, DC 20503, or email:
Requests for information, including copies of the information collection proposed and supporting documentation, should be directed to the Senior Privacy Program Manager: Christopher A. Marsalis, Tennessee Valley Authority, 400 W Summit Hill Dr. (WT 5D), Knoxville, Tennessee 37902-1401; telephone (865) 632-2467 or by email at
Federal Aviation Administration (FAA), DOT.
Notice.
The FAA announces its determination that the noise exposure maps submitted by the Port Authority of New York and New Jersey for Newark Liberty International Airport are in compliance with applicable requirements.
The effective date of the FAA's determination on the noise exposure maps is January 15, 2019.
Eastern Region Airports Division (AEA-600), Andrew Brooks, Environmental Program Manager, Federal Aviation Administration, AEA-600, 1 Aviation Plaza, Jamaica, New York, 11434, Telephone: (718) 553-3330.
This notice announces that the FAA finds that the noise exposure maps submitted for Newark Liberty International Airport under the provisions of 49 U.S.C. 47501 et. seq (Aviation Safety and Noise Abatement Act) and 14 CFR part 150 are in compliance with applicable requirements of 14 CFR part 150, effective January 13, 2004.
Under 49 U.S.C. Section 47503 of the Aviation Safety and Noise Abatement Act (hereinafter referred to as “the Act”), an airport operator may submit to the FAA noise exposure maps which meet applicable regulations and which depict non-compatible land uses as of the date of submission of such maps, a description of projected aircraft operations during a forecast period that is at least five (5) years in the future, and the ways in which such operations will affect such maps. The Act requires such maps to be developed in consultation with interested and affected parties in the local community, government agencies, and persons using the airport. An airport operator who has submitted noise exposure maps that are found by the FAA to be in compliance with the requirements of 14 CFR part 150, promulgated pursuant to the Act, may submit a noise compatibility program for FAA approval which sets forth the measures the operator has taken or proposes to take to reduce existing non-compatible uses and prevent the introduction of additional non-compatible uses.
The FAA has completed its review of the noise exposure maps and accompanying documentation submitted by the Port Authority of New York and New Jersey. The documentation that constitutes the “Noise Exposure Maps” (NEM) as defined in Section 150.7 includes a 2019 Base Year NEM, Figure 5-1, and a 2024 Future Year NEM, Figure 5-2, located in Chapter 5 of the NEM Report. Details of the NEM contours are provided by Runway end in Figures 5-3 through 5-6 of Chapter 5. The figures contained within Chapter 5 are scaled to fit within the report context; however, the official, to scale, 2019 Base Year NEM and 2024 Future Year NEM are identified as Figures 5-9 and 5-10 and are both located in an attachment to the official NEM Report submittal.
The Noise Exposure Maps contain current and forecast information including the depiction of the airport and its boundaries, the runway configurations, land uses such as single and two-family residential; multi-family residential; mixed residential and commercial; commercial and office; industrial and manufacturing; transportation, parking and utilities; public facilities and institutions; unclassified; open space, cemetaries, and outdoor recreation; vacant land; places of worship; schools; historic
As discussed in Chapter 6 of the NEM Report, the Port Authority of New York and New Jersey provided the general public the opportunity to review and comment on the NEMs. This public comment period opened on September 13, 2018 and closed on October 15, 2018. Public workshops for the Draft NEMs were held on September 25 and September 26, 2018. All comments received during the public comment period and throughout the development of the NEMs, as well as responses to these comments, are contained in Appendix H of the NEM Report.
The FAA has determined that these noise exposure maps and accompanying documentation are in compliance with applicable requirements. This determination is effective on January 15, 2019.
FAA's determination on an airport operator's noise exposure maps is limited to a finding that the maps were developed in accordance with the procedures contained in Appendix A of 14 CFR part 150. Such determination does not constitute approval of the applicant's data, information or plans, or a commitment to approve a noise compatibility program or to fund the implementation of that program. If questions arise concerning the precise relationship of specific properties to noise exposure contours depicted on a noise exposure map submitted under Section 47503 of the Act, it should be noted that the FAA is not involved in any way in determining the relative locations of specific properties with regard to the depicted noise contours, or in interpreting the noise exposure maps to resolve questions concerning, for example, which properties should be covered by the provisions of Section 47506 of the Act. These functions are inseparable from the ultimate land use control and planning responsibilities of local government. These local responsibilities are not changed in any way under Part 150 or through FAA's review of noise exposure maps. Therefore, the responsibility for the detailed overlaying of noise exposure contours onto the map depicting properties on the surface rests exclusively with the airport operator that submitted those maps, or with those public agencies and planning authorities with which consultation is required under Section 47503 of the Act. The FAA has relied on the certification by the airport operator, under Section 150.21, that the statutorily required consultation has been accomplished.
Copies of the full noise exposure map documentation and of the FAA's evaluation of the maps are available for examination at the following locations:
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 1, 2019.
Send comments identified by docket number FAA-2016-7819 using any of the following methods:
•
•
•
•
Deana Stedman, AIR-673, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198, phone and fax 206-231-3187, email
This notice is published pursuant to 14 CFR 11.85.
Under part 235 of Title 49 of the Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document provides the public notice that by a document dated May 23, 2019, Union Pacific Railroad Company (UP) petitioned the Federal Railroad Administration (FRA) seeking approval to discontinue or modify a signal system. FRA assigned the petition Docket Number FRA-2019-0043.
Specifically, UP requests approval to discontinue cab signals between control point (CP) S001 at milepost (MP) 0.60 and CP S082 at MP 81.60 on the Portland subdivision in the state of Oregon.
UP states the reason for the proposed discontinuance is a positive train control (PTC) system, compliant with 49 CFR part 236, subpart I, and certified accordingly, was placed in service on the entire Portland subdivision, including the limits described above, in March 2017. Since that time, over 2.5 million train-miles of PTC operations have been accumulated on the Portland subdivision without a critical anomaly. Additionally, PTC operations have been conducted under the provisions of a waiver, Docket Number FRA-2016-0108, which allows for the use of PTC in lieu of cab signals on the Portland subdivision and elsewhere on UP where automatic cab signal (ACS), automatic train control, and automatic train stop systems are present.
To ensure that an equivalent or greater level of safety is maintained upon discontinuance of the ACS and to meet the requirements of 49 U.S.C. 20157(j)(1), UP asserts it will promulgate operating rules requiring that any train on which PTC fails to initialize, cuts out, or malfunctions comply with operating restrictions in accordance with 49 CFR 236.1029, while operating within former ACS limits of the Portland subdivision. UP explains it believes that the combination of the current levels of PTC reliability and, utilization, combined with the application of operating restrictions under failure conditions result in a level of safe operation which justifies discontinuance of the ACS system on the Portland subdivision.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by July 26, 2019 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that on April 15, 2019, the American Short Line and Regional Railroad Association (ASLRRA) petitioned the Federal Railroad Administration (FRA) for an amended waiver of compliance from certain provisions of the Federal hours of service laws contained at 49 U.S.C. 21103(a)(4), which, in part, require a train employee to receive 48 hours off duty after initiating an on-duty period for 6 consecutive days. FRA assigned the petition Docket Number FRA-2009-0078.
Specifically, ASLRRA seeks to amend its existing waiver to add three member railroads that did not participate in the original waiver, but in the first quarter of 2019 determined that they now wish to participate. ASLRRA states the following railroads expressed a desire to participate in the waiver, and maintain
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by July 26, 2019 will be considered by FRA before final action is taken. FRA reserves the right to grant relief in this docket prior to the expiration of the comment period. FRA will condition any such grant of relief on subsequent consideration of relevant comments submitted to the docket within the comment period. Comments received after the comment period ends will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 11, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0089 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel TRANQUILO is:
The complete application is available for review identified in the DOT docket as MARAD-2019-0089 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
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, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 11, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0090 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ALCHEMY is:
The complete application is available for review identified in the DOT docket as MARAD-2019-0090 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
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, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 11, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0091 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel NORTH SEA is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
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, to
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 11, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0092 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel REEL DIVE is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
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, to
By Order of the Maritime Administrator.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On May 16, 2019, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. GEREMEYEV, Ruslan, Russia; DOB 10 May 1978; citizen Russia; Gender Male (individual) [MAGNIT].
Designated pursuant to section 404(a)(3) and 406 of the Russia and Moldova Jackson-Vanik Repeal and Sergei Magnitsky Rule of Law Accountability Act of 2012 (The Magnitsky Act), for acting as an agent of or on behalf of a person in a matter relating to extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against individuals seeking to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections in Russia.
2. KARLOV, Gennady Vyacheslavovich (Cyrillic: КАРЛОВ, Геннадий Вячеславович); DOB 27 Feb 1960; alt. DOB 1966; Gender Male (individual) [MAGNIT].
Designated pursuant to section 404(a)(1) and 406 of the Magnitsky Act, for participating in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
3. KOSSIEV, Sergey Leonidovich (Cyrillic: КОССИЕВ, Сергей Леонидович) (a.k.a. KOSSIYEV, Sergei); DOB 19 May 1975; Gender Male; Head of the Institution, Captain of Internal Service, Penal Colony IK-7 (individual) [MAGNIT].
Designated pursuant to section 404(a)(2)(B) and 406 of the Magnitsky Act, for being responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against individuals seeking to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections in Russia.
4. TRIKULYA, Elena Anatolievna, Russia; DOB 18 Mar 1975; Gender Female (individual) [MAGNIT].
Designated pursuant to section 404(a)(1) and 406 of the Magnitsky Act, for participating in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
5. VISMURADOV, Abuzayed, Chechen Republic, Russia; DOB 21 Dec 1975; Gender Male; Commander of the Special Quick-Reaction Detachment (SOBR) Team “Terek” (individual) [MAGNIT].
Designated pursuant to section 404(a)(2)(B) and 406 of the Magnitsky Act, for being responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against individuals seeking to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections in Russia.
1. TEREK SPECIAL RAPID RESPONSE TEAM (a.k.a. SPECIAL DIVISION OF FIRST RESPONDERS, CHECHNYA (SOBR)), Chechen Republic, Russia [MAGNIT].
Designated pursuant to section 404(a)(2)(B) and 406 of the Magnitsky Act, for being responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against individuals seeking to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections in Russia.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning real estate mortgage investment conduits.
Written comments should be received on or before August 12, 2019 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or
The following paragraph applies to all of the collections of information covered by this notice.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning application for enrollment to practice before the Internal Revenue Service.
Written comments should be received on or before August 12, 2019 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or copies of the form should be directed to Kerry Dennis, at (202) 317-5751 or Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.