Change Requests

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[NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N)

Key Information

Abstract

CDC's Newborn Screening and Molecular Biology Branch (NSMBB) is developing a National Newborn Screening Data Platform (known as ED3N) that will address analytic and post-analytic challenges and promote sharing of molecular, biochemical, and clinical information amongst state-based newborn screening (NBS) partners. The information shared will help NSMBB and newborn screening partners be better equipped to assess disease risk and will help harmonize approaches for disease detection in newborns. Given the rarity of newborn screening diseases, it is imperative that data be collected and analyzed at a national level in order to glean useful insights and trend analyses. The NSMBB is best-suited to oversee this work given its role in providing technical assistance to NBS programs nationally. This is an Extension of the previous submission.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC Chapter 6A 300b-8 to 300b-15	View Law

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[PHIC] Fellowship Management System

Key Information

Abstract

The Centers for Disease Control and Prevention (CDC) uses Fellowship Management System (FMS) to collect, process, and manage data from nonfederal applicants seeking training or public health support services through CDC fellowships. FMS is used to electronically submit fellowship applications, submit fellowship host site proposals, track fellows’ activities during their fellowships, and maintain fellowship alumni directories online. FMS is a key tool in CDC’s efforts to maintain and develop a robust public health workforce. This Revision Request proposes significant streamlining of the fellowship management functions housed within FMS and makes updates to the burden estimates.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 301	View Law

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Data Collection to Support Eligibility Determinations and Enrollment for Small Businesses in the Small Business Health Options Program (CMS-10439)

Key Information

Abstract

On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, collectively referred to as "The Affordable Care Act." The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges (Exchanges), and the assurance of coordination between Medicaid, CHIP, and Exchanges. Through the Small Business Health Options Program (SHOP), the new Exchanges will assist qualified small employers in facilitating the enrollment of their employees in Qualified Health Plans (QHPs) offered in the small group market. The Exchanges, which will offer these QHPs, will become operational on January 1, 2014. Employers will be able to begin applying for coverage through the SHOP October 1, 2013, for coverage beginning as early as January 1, 2014. The employer's application for the SHOP will be a single, streamlined form that will be used to determine employer eligibility for the SHOP. The submission seeks OMB approval of the data collection elements needed to support eligibility determinations for small businesses in the SHOP.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 148 1311	View Law

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General Reporting and Recordkeeping by Savings Associations

Key Information

Abstract

Savings associations are required to produce certain reports and records, which establish prudent management controls. This allows examiners to determine whether savings associations are being operated safely, soundly, and in compliance with regulations.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

12 USC 1461 et seq.	View Law

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Collection of Research Code Non-Disclosure Agreement Information

Key Information

Abstract

This information collection request is an Non-Disclosure Agreement (NDA) used for domestic and foreign entities to obtain and use the NRC’s nuclear safety analytical computer codes. NRC develops and uses computer codes to independently model and evaluate safety issues associated with the licensed use of radioactive materials. As a global leader in nuclear regulatory research and safety assessment, NRC is frequently approached by domestic and international organizations requesting copies of NRC computer codes. In general, to obtain an NRC code an individual or organization first agrees to not redistribute the code (i.e., non-disclosure) through an NDA. The NDA also imposes terms and conditions for code use, and requires notification to NRC of code errors, code modifications, and updated user information. An officially signed and executed NDA of users agreeing to the terms and conditions is current NRC practice for access to NRC-developed computer codes. Once the NDA has been signed, received, reviewed, and accepted, the requesting individual or organization is given access to the requested code. The information collection enables the NRC to ensure that proper procedures and agreements are in place to guide the distribution and use of these codes according to NRC and U.S. Government policies and international agreements such as import-export restrictions and intellectual property rights. Further information collection on code errors and modifications by code users permits NRC to maintain control and quality of its codes in a timely and efficient manner.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 83 - 703 1-311	View Law

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Regulation SBSR (Rules 900 - 912) – Reporting and Dissemination of Security-Based Swap Information

Key Information

Abstract

The Dodd-Frank Act amended the Exchange Act to require the Commission to adopt rules providing for, among other things (i) the reporting of security-based swaps ("SBSs") to a registered security-based swap data repository ("SDR") or to the Commission; and (ii) real-time public dissemination of SBS transaction, volume, and pricing information. Pursuant to Sections 763 and 766 of Title VII of the Dodd-Frank Act, the Commission adopted Regulation SBSR to fulfill these requirements.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 203 763, 766	View Law

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Rule 13e-1

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Abstract

Section 13(e) of the Securities Exchange Act of 1934 (the “Act”) makes it unlawful for an issuer to purchase its own equity securities unless the purchase is in compliance with such rules and regulations as set forth by the Commission for protection of public interest or for the protection of the investors. In order to facilitate compliance with Section 13(e), the Commission adopted Rule 13e-1 (17 CFR 240.13e-1). Rule 13e-1 states that an issuer that has received notice that it is the subject of a tender offer made under Section 14(d)(1) of the Act, that has commenced under Rule 14d-2, cannot purchase any of its equity securities during the tender offer unless the issuer first files a statement with the Commission containing the required information under Rule 13e-1. This rule is in keeping with the Commission’s statutory responsibility to prescribe rules and regulations that are necessary for the protection of investors. A principal function of the Federal securities laws’ disclosure provisions is to make information available to the securities markets. The Commission uses very little of the collected information for itself, except on an occasional basis in the enforcement of the securities laws. The information required by the Commission assures the public availability and dissemination of such information.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78c, 78l, 78m, 78n, 78o(d)	View Law

15 USC 78w(a), 89ll	View Law

15 USC 80a-8, 80a-24, 80a-29, 80a37	View Law

15 USC 77g, 77j, 77s(a)	View Law

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Company-Run Annual Stress Test Reporting Template and Documentation for Covered Institutions with Total Consolidated Assets of $250 Billion or More

Key Information

Abstract

Section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) requires certain financial companies, including national banks and federal savings associations, to conduct annual stress tests and requires the primary financial regulatory agency of those financial companies to issue regulations implementing the stress test requirements. Under section 165(i)(2), a covered institution is required to submit to the Board of Governors of the Federal Reserve System (Board) and to its primary financial regulatory agency a report at such time, in such form, and containing such information as the primary financial regulatory agency may require.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 203 165(i)	View Law

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Rule 17f-1(g), 17 CFR 240.17f-1(g): Recordkeeping Requirements for the Lost & Stolen Securities Program

Key Information

Abstract

Rule 17f-1(g), 17 CFR 240.17f-1(g), requires that all reporting institutions (i.e., every national securities exchange, member thereof, registered securities association, broker, dealer, municipal securities dealer, registered transfer agent, registered clearing agency, participant therein, member of the Federal Reserve System, and bank insured by the FDIC) maintain and preserve a number of documents related to their participation in the Lost and Stolen Securities Program under Rule 17f-1.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78q(f)	View Law

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Form S-4 - Registration Statement

Key Information

Abstract

Form S 4 (17 CFR 239.25) is a form used for registration under the Securities Act of 1933 of securities to be issued in: (1) transactions specified in Securities Act Rule 145(a) (17 CFR 230.145(a)), which include certain reclassifications, mergers, consolidations, and transfers of assets requiring a vote of or consent by security holders; (2) mergers in which the applicable state law would not require the solicitation of the votes or consents of all of the security holders of the company being acquired; (3) exchange offers for the securities of the issuer or another entity; (4) public reoffering’s or resales of any such securities acquired pursuant to the registration statement; and (5) more than one of the above listed transactions registered on one registration statement. The purpose of the information collection is to ensure the adequacy of information available to investors in connection with registered business combination transactions.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 77g, 77j, 77s(a)	View Law

15 USC 78c, 78l, 78m, 78n, 78o(d)	View Law

15 USC 78w(a), 78ll	View Law

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Rule 19b-1 (17 CFR 270.19b-1) under the Investment Company Act of 1940 - Frequency of Distribution of Capital Gains

Key Information

Abstract

Section 19(b) of the Investment Company Act of 1940 authorizes the Commission to regulate registered investment company (“fund”) distributions of long-term capital gains made more frequently than once every twelve months. Accordingly, rule 19b-1(e) permits a fund to apply to the Commission for permission to distribute long-term capital gains that would otherwise be prohibited by the rule if the fund did not foresee the circumstances that created the need for the distribution. The application must set forth the pertinent facts and explain the circumstances that justify the distribution. An application that meets those requirements is deemed to be granted unless the Commission denies the request within 15 days after the Commission receives the application. Rule 19b-1(e) allows a fund, in unforeseen circumstances, to request timely authorization to make a distribution that would not otherwise be permitted by the rule. The Commission uses the information required by paragraph (e) to determine whether a request should be granted under this paragraph.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 80a	View Law

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NASA Property in the Custody of Award Recipients

Key Information

Abstract

To ensure accurate reporting of Government-owned, contractor-held property on the financial statements and to provide information necessary for effective property management in accordance with Federal Acquisition Regulation (FAR) Part 45, National Aeronautics and Space Administration (NASA) obtains summary data annually from the official Government property records maintained by its award recipients with contracts, grants and cooperative agreements. The information is submitted via the NASA Form 1018, at the end of each fiscal year. Additional information submitted to approve the accuracy of the award recipient property management system compliance is submitted via NASA Form 1019, at the beginning of awards with NASA property in the hands of award recipients; and same information gathered by Federal agencies assisting NASA according to risk matrix. Information for property management system in accordance with FAR Part 45, NASA is the agency responsible for contract award administration shall conduct an analysis of the award recipient's property management policies, procedures, practices, and systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

31 USC 3512	View Law

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Federal-State Unemployment Insurance Program Data Exchange Standardization

Key Information

Abstract

The Department is required by the Middle Class Tax Relief and Job Creation Act of 2012 to designate eXtensible Markup Language (XML) as a data exchange standard. The data exchange standards help improve the interoperability of these systems that collect and exchange information for UI administrative purposes. Through this regulation, the Department makes use of data exchange standards for ICON and SIDES. To improve UI program operations by states, the Department has been the facilitating entity for development and implementation of automated systems that states may adopt for efficiently processing claims and improving program integrity. These automated systems, which have been developed through a collaborative effort with states and the National Association of Workforce Agencies (NASWA), have replaced manual paper processing with automated exchanges of information between states as well as those between states and employers. The Department provides funding to facilitate the development and implementation of these automated systems, and encourages the use of these systems by states. The Federal requirement to use this standard requires the Department to establish, through regulation, that all such exchanges of electronic information must use XML to comply with the Act.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 1111	View Law

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Protections for Transit Workers under Section 5333(b) Urban Program

Key Information

Abstract

Under 49 U.S.C. 5333(b), when Federal funds are used to acquire, improve, or operate a transit system, the Department must ensure that the recipient of those funds establishes arrangements to protect the rights of affected transit employees. Federal law requires such arrangements to be ``fair and equitable,'' and the Department of Labor (DOL or "the Department") must certify the arrangements before the U.S. Department of Transportation's Federal Transit Administration (FTA) can award certain funds to grantees. These employee protective arrangements must include provisions that may be necessary for the preservation of rights, privileges, and benefits under existing collective bargaining agreements or otherwise; the continuation of collective bargaining rights; the protection of individual employees against a worsening of their positions related to employment; assurances of employment to employees of acquired transportation systems; assurances of priority of reemployment of employees whose employment is ended or who are laid off; and paid training or retraining programs. 49 U.S.C. 5333(b)(2). Pursuant to 29 CFR Part 215, upon receipt of copies of applications for Federal assistance subject to 49 U.S.C. 5333(b) from the FTA, together with a request for the certification of employee protective arrangements from the Department of Labor, DOL will process those applications, which must be in final form. The FTA will provide the Department with the information necessary to enable the Department to process employee protections for certification of the project. This ICR contains the information collected when DOL refers for review the grant application and the proposed terms and conditions to unions representing transit employees in the service area of the project and to the applicant and/or sub-recipient.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

49 USC 5333(b)	View Law

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Rule 15Fi-2 Trade Acknowledgment and Verification of Security-Based Swap Transactions

Key Information

Abstract

Rule 15Fi-2, 17 CFR 240.15Fi-2, prescribes documentation standards for the timely and accurate acknowledgment and verification of SBS transactions by SBS Entities. The rule contains seven paragraphs: (a) the trade acknowledgment obligations of specific SBS Entities; (b) the prescribed time frames under which a trade acknowledgment must be provided; (c) the form and content requirements of the trade acknowledgment; (d) SBS Entities’ verification obligations; (e) a limited exception from the requirement to provide a clearing agency a trade acknowledgment in a clearing transaction; (f) a limited exception from the requirement to provide a trade acknowledgment for certain transactions executed on a security-based swap execution facility or a national securities exchange or accepted for clearing by a clearing agency; and (g) a limited exemption from the requirements of Exchange Act Rule 10b-10 for a broker-dealer acting as principal for its own account in a security-based swap transaction.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78o-8(i)	View Law

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Form N-8B-4 under the Investment Company Act of 1940 - Registration Statement of Face-Amount Certificate Companies

Key Information

Abstract

Section 8(b) of the Investment Company Act of 1940 (the “Act”) requires every registered investment company to file a registration statement with the Commission that includes certain information about the company and recites the company’s policies on certain significant matters. Form N-8B-4 under the Act (17 CFR 274.14) is the form used by face-amount certificate companies to satisfy these requirements. Among other things, the form requires a face-amount certificate company to disclose information about the date and form of organization of the company, securities issued, its controlling persons, and its current and contemplated business. Additionally, the form requires disclosure about the face-amount certificate company’s fundamental policies, including its investment, borrowing, and lending policies. Further, the form requires a face-amount certificate company to provide financial statements as well as disclosures about the company’s investment adviser, depositaries, management personnel, and the compensation paid to directors, officers, and certain employees. The Commission uses the information provided in the collection of information to determine a face-amount certificate company’s compliance with Section 8(b) of the Act.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 80a-8(b)	View Law

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Rule 6a-4 under the Securities Exchange Act of 1934 and Form 1-N under the Securities Exchange Act of 1934

Key Information

Abstract

Rule 6a-4 directs certain futures markets that wish to trade security futures products to register with the Commission on Form 1-N. The rule is designed to provide the Commission with information that would help enable it to ensure that the activities of these Security Futures Product Exchanges were consistent with the Exchange Act. Rule 6a-4 permits respondents to make certain information available on the Internet and to notify the Commission of its web location. The Internet has developed the potential to ease compliance burdens for respondents and increase the speed, accuracy, and availability of information, generating benefits to investors and financial markets. SEC staff is considering ways to reduce respondents’ paperwork burden, including using electronic means to submit Form 1-N.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78f(g)	View Law

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Dissemination of Quotations -- Rule 602 of Regulation NMS

Key Information

Abstract

Section 11A(a)(2) of the Securities Exchange Act of 1934 (“Exchange Act”) directs the Securities and Exchange Commission (“Commission”) to use its authority under the Exchange Act to facilitate the establishment of a national market system in which, among other things, brokers, dealers, and investors have access to information on securities quotations and transactions. Moreover, the Commission is authorized, under Sections 11A(c)(1)(B) and (F) of the Exchange Act, to assure the prompt, accurate and reliable distribution of quotation information and to assure the fairness and usefulness of the form and content of such information. To achieve these statutory objectives, the Commission promulgated Rule 11Ac1-1, designated as Rule 602 of Regulation NMS, 17 CFR 242.602. Rule 602 contains two related collections of information. The first collection of information is found in Rule 602(a). This requirement obligates each national securities exchange and national securities association to make available to quotation vendors for dissemination to the public the best bid, best offer, and aggregate quotation size for each “subject security,” as defined under the Rule. The second collection of information is found in Rule 602(b). This requirement obligates each exchange member and over-the-counter (“OTC”) market maker that is a “responsible broker or dealer,” as defined under the Rule, to communicate to an exchange or association its best bids, best offers, and quotation sizes for subject securities.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78a	View Law

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Rule 19b-5 and Form PILOT

Key Information

Abstract

Rule 19b-5 permits a self-regulatory organization (SRO) to operate a pilot trading system, under certain conditions, for two years without submitting a proposed rule change to the Commission pursuant to Rule 19b-4. SROs availing themselves of Rule 19b-5 are required to file a Form PILOT at least 20 days before com- mencing operation of the system. SROs are also required to file notices of material systems changes and quarterly activity re- ports on Form PILOT.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

17 USC 78s(b)	View Law

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Federal Plant Pest and Noxious Weeds Regulations

Key Information

Abstract

This collection contains information requirements, including the application for permits, to import regulated articles such as plant pests, noxious weeds, or soil, or to move regulated articles interstate. It also contains information requirements for businesses requiring APHIS approval to process regulated garbage.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

7 USC 7712	View Law

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Complaints Submission Process under the No Surprises Act (CMS-10779)

Key Information

Abstract

Enacted on December 27, 2020, the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act (CAA), amended the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), and the Internal Revenue Code of 1986 (Code). The No Surprise Act implements provisions that protect individuals from surprise medical bills for emergency services, air ambulance services furnished by nonparticipating providers, and non-emergency services furnished by nonparticipating providers at participating facilities in certain circumstances. Additionally, the No Surprises Act sets forth a complaints processes with respect to potential violations of balance billing requirements set forth in the No Surprises Act. The No Surprises Act provides federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise medical bills arise most frequently. The 2021 interim final regulations “Requirements Related to Surprise Billing; Part I” (86 FR 36872, 2021 interim final regulations) issued by the Departments of Health and Humans Services (HHS), Department of Labor (DOL), the Department of Treasury (collectively, the Departments), implement provisions of the No Surprises Act that apply to group health plans, health insurance issuers offering group or individual health insurance coverage that provide protections against balance billing and out-of-network cost sharing with respect to emergency services, non-emergency services furnished by nonparticipating providers at certain participating health care facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services. The No Surprises Act and the 2021 interim final regulations directs the Departments of Labor, Health and Human Services, and the Department of Treasury (collectively, “the Departments”) to establish a process to receive complaints regarding violations of the application of qualifying payment amount (QPA) requirements by group health plans and health insurance issuers offering group or individual health coverage. The No Surprises Act also directs HHS to establish a process to receive consumer complaints regarding violations by health care providers, facilities, and providers of air ambulance services regarding balance billing requirements and to respond to such complaints within 60 days.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 120 - 260 No Surprises Act - 102, 104	View Law

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Rule 302 (17 CFR 242.302) Recordkeeping Requirements for Alternative Trading Systems

Key Information

Abstract

Rule 302 provides that, as a condition of operating as a broker- dealer, alternative trading systems must keep certain records regarding subscribers to their system, daily trading summaries and time-sequenced records of order information in the alternative trading systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 78a	View Law

Presidential Action:

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Form F-3 Registration Statement

Key Information

Abstract

The Securities Act of 1933 (the “Securities Act”) was designed to prevent misrepresentation, deceit and other fraudulent acts and practices in the sale of securities. Section 5 of the Securities Act requires that a registration statement be filed before any security is publicly offered, and that the registration statement be effective before any security is sold. Section 7 of the Securities Act and Schedule A outlines the information that must be contained in a registration statement. Section 7 gives the Commission the authority to vary such disclosure for various classes of issuers and securities. The Commission has used its statutory authority to develop a number of specialized registration statement forms that tailor disclosure requirements based on the type of offering, issuer, or other parameters, thereby eliminating burdensome and unnecessary requirements while maintaining investor protection. Form F-3 (17 CFR 239.33) is a short-form securities registration statement that is available to any foreign private issuer as defined in Securities Act Rule 405 (17 CFR 230.405) that meets certain registrant and transaction eligibility requirements under the form. The purpose of the information collection is to provide disclosure of material financial and other information with which investors may evaluate the merits of securities in order to make investment decisions.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 77c, 77f, 77g, 77h, 77j	View Law

15 USC 77s(a), 77z-3	View Law

15 USC 78c(b), 78l, 78m, 78o(d)	View Law

15 USC 78w(a), 78mm	View Law

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Safeguarding Covered Defense Information, Cyber Incident Reporting, and Cloud Computing

Key Information

Abstract

This collection implements mandatory tracking and reporting of intrusions on unclassified networks or contractor information technology systems that process DoD information or those contractors designated as providing operationally critical support. DoD is required by statute to establish programs and activities to protect DoD information and DoD information systems, including information and information systems operated and maintained by contractors or others in support of DoD activities. Offerors and contractors must report cyber incidents on unclassified networks or information systems, within cloud computing services, and when they affect contractors designated as providing operationally critical support, as required by statute.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 112 - 239 941	View Law

41 USC 1303	View Law

Pub.L. 113 - 291 1632	View Law

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Civil Rights Discrimination Complaint

Key Information

Abstract

This collection is used to simplify the complainant's burden in filing a Civil Rights Discrimination complaint by identifying the information necessary to resolve the complaint.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 6104	View Law

42 USC 6105	View Law

42 USC 6106	View Law

42 USC 6107	View Law

29 USC 794	View Law

42 USC 2000d-1	View Law

42 USC 2000d-3	View Law

42 USC 6102	View Law

42 USC 2000d-4	View Law

42 USC 6101	View Law

42 USC 2000d-2	View Law

42 USC 6103	View Law

Presidential Action: