Change Requests

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Hospital Outpatient Quality Reporting (OQR) Program (CMS-10250)

Key Information

Abstract

Section 109(a) of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432) amended section 1833(t) of the Social Security Act by adding a new subsection (17) that affects the payment rate update applicable to Outpatient Prospective Payment System (OPPS) payments for services furnished by hospitals in outpatient settings on or after January 1, 2009. Section 1833(t)(17)(A) of the Social Security Act, which applies to hospitals as defined under section 1886(d)(1)(B) of the Social Security Act, requires that hospitals that fail to report data required for quality measures selected by the Secretary in the form and manner required by the Secretary under section 1833(t)(17)(B) of the Social Security Act will incur a reduction in their annual payment update (APU) factor to the hospital outpatient department fee schedule by 2.0 percentage points. Hospital OQR Program payment determinations are made based on Hospital OQR Program quality measure data reported and supporting forms submitted by hospitals as specified through rulemaking. To reduce burden, a variety of different data collection mechanisms are employed, with every consideration taken to employ existing data and data collection systems.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 109 - 432 109(a)	View Law

Pub.L. 111 - 148 3014	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Statutory Exemption for Cross-Trading of Securities

Key Information

Abstract

The Statutory Exemption for Cross-Trading of Securities regulation (29 CFR 2550.408b-19) implements the content requirements for the written cross-trading policies and procedures required under section 408(b)(19)(H) of ERISA, as added by section 611(g) of the Pension Protection Act of 2006, Public Law 109-280 (the PPA). Section 611(g)(1) of the PPA created a statutory exemption, added to section 408(b) of ERISA as subsection 408(b)(19), that exempts from the prohibitions of sections 406(a)(1)(A) and 406(b)(2) of ERISA those cross-trading transactions involving the purchase and sale of a security between an account holding assets of a pension plan and any other account managed by the same investment manager, provided that certain conditions are satisfied. On October 7, 2008, the Department issued final regulations regarding cross-trading policies and procedures (73 FR 58450). The regulation provides that the policies and procedures for cross-trading under the statutory exemption must meet certain content requirements. The statutory exemption requires, as a condition to exemptive relief, that an investment manager's policies and procedures regarding cross-trading be provided in advance to the fiduciary of any plan that is considering agreeing to allow its assets to be managed under the investment manager's cross-trading program. The investment manager is also required, under the statutory exemption, to designate a compliance officer responsible for periodically reviewing the investment manager's cross-trading program to ensure compliance with the investment manager's cross-trading written policies and procedures. The statutory exemption requires the compliance officer to issue an annual report to each plan fiduciary describing the steps performed during the course of the review, the level of compliance, and any specific instances of noncompliance. The exemption does not require any reporting or filing with the Federal government.

Federal Register Notices

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

Authorizing Statutes

29 USC 1108(b)(19)(H)	View Law

Pub.L. 109 - 280 611(g)(1), (3)	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Class Exemption for Certain Transactions Involving Purchase of Securities where Issuer May Use Proceeds to Reduce or Retire Indebtedness to Parties in Interest (PTE 1980-83)

Key Information

Abstract

Class exemption PTE 80-83, granted on November 4, 1980, allows employee benefit plans to purchase securities, which may aid the issuer of the securities to reduce or retire indebtedness to a party in interest. Entities who rely on the exemption are mainly banks that purchase, on behalf of employee benefit plans, securities issued by a corporation indebted to the bank that is a party in interest to the plan. The principal requirements of the exemption are that the securities must be sold as part of a public offering, and the price paid for the securities must not be in excess of the original offering price. A plan fiduciary may not engage in certain transactions with parties in interest as defined in section 3(14) of ERISA, including plan fiduciaries, sponsoring employers, employee organizations, service providers and affiliates, unless an exemption applies to the transaction. This exemption also provides relief from the prohibited transaction provisions of Section 4975 of the Internal Revenue Code (the Code).

Federal Register Notices

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

Authorizing Statutes

29 USC 408(a)	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Recreation Use Data Report

Key Information

Abstract

The information will allow Reclamation to continue to evaluate program and management effectiveness of existing recreation and concessionaire resources and facilities and validate effective public use of managed recreation resources located on Reclamation project lands in the 17 Western States.

Federal Register Notices

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

Authorizing Statutes

16 USC 460l-31-460l-34	View Law

16 USC 460l	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

DOI Access & Consent Forms

Key Information

Abstract

The Department of the Interior (DOI) developed the DI-4016, Request for Individual Access to Records Protected under the Privacy Act, and DI-4017, Consent for Disclosure of Records Protected under the Privacy Act, forms for individuals to submit requests for accessing, and consenting to the disclosure of, records protected under the Privacy Act of 1974, as amended, 5 U.S.C. 552a. The DI-4016, Request for Individual Access to Records Protected under the Privacy Act, form is used by individuals seeking access to their records and any information pertaining to them that are maintained in DOI’s systems of records. The DI-4017, Consent for Disclosure of Records Protected under the Privacy Act, form provides written consent of the individual to whom the record pertains when disclosing records to another person or an agency. The Privacy Act provides that "the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.” Therefore, these forms may also be used by a parent or legal guardian. These forms were based on the templates provided in the OMB Memorandum M-21-04, Modernizing Access to and Consent for Disclosure of Records Subject to the Privacy Act, issued on November 12, 2020, which implements the requirements of the Creating Advanced Streamlined Electronic Services for Constituents Act of 2019 (“CASES Act”). The CASES Act was issued in an effort to modernize the Privacy Act request process by requiring agencies to accept access and consent forms from individuals properly identity-proofed and authenticated remotely through a digital service option in addition to an agency’s existing process. The CASES Act also requires the forms to be posted on the agency website's privacy program page and the website updated to include instructions on how individuals may submit requests digitally.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 116 - 50 3	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Request for Department of State Personal Identification Card

Key Information

Abstract

The collection of the information requested on the DS-1838 and DS-7783 is necessary for all Department non-employees who need a PIV. They are required to submit an application for a Personal Identification Card (DS-1838 domestically or DS-7783 overseas) at the time of hire. The information collected on the form is necessary to verify personal identity as required by the Federal Information Processing Standard Publication 201 (FIPS 201) and Homeland Security Presidential Directive 12 (HSPD 12). Employees must also use these forms, but the Paperwork Reduction Act does not apply to them; therefore, their numbers are not counted in this request.

Federal Register Notices

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

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Pipeline Corporate Security Reviews and TSA Security Directive Pipeline– 2021–02 Series

Key Information

Abstract

Under the Aviation and Transportation Security Act (ATSA)and delegated authority from the Secretary of Homeland Security, TSA is tasked with developing policies, strategies, and plans for dealing with transportation security. TSA carries out this responsibility in the pipeline mode by assessing current industry security practices by way of its Pipeline Corporate Security Review (PCSR) program.

Federal Register Notices

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

Authorizing Statutes

49 USC 114(d)	View Law

6 USC 1207	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

NSPS for Kraft Pulp Mills (40 CFR Part 60, Subpart BB) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for the regulations published at 40 CFR Part 60, Subpart BB were proposed on September 24, 1976, promulgated on February 23, 1978, and amended on April 4, 2014. These regulations apply to the following facilities at existing kraft pulp mills that commenced construction, reconstruction, or modification after September 24, 1976 and on or before May 23, 2013: recovery furnaces, smelt dissolving tanks, lime kilns, digester systems, brown stock washer systems, black liquor oxidation systems, multiple effect evaporator systems and condensate stripper systems. In pulp mills where kraft pulping is combined with neutral sulfite semi-chemical pulping, the provisions of this Subpart are applicable when any portion of the material charged to an affected facility is produced by the kraft pulping operation. This information is being collected to assure compliance with 40 CFR Part 60, Subpart BB. New facilities that commenced construction, modification or reconstruction after May 23, 2013 are subject to regulation under 40 CFR Part 60 Subpart BBa. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

NSPS for Grain Elevators (40 CFR part 60, subpart DD) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for the regulations published at 40 CFR Part 60, Subpart DD were proposed on January 18, 1977, and promulgated on August 3, 1978. These regulations apply to existing facilities and new facilities located at grain elevators: each truck unloading station, truck loading station, railcar unloading station, railcar loading station, grain dryer, and all grain handling operations commencing construction, modification or reconstruction after August 3, 1978. This information is being collected to assure compliance with 40 CFR Part 60, Subpart DD. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq.	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

NESHAP for Stationary Reciprocating Internal Combustion Engines (40 CFR part 63, subpart ZZZZ) (Final Rule)

Key Information

Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Stationary Reciprocating Internal Combustion Engines (40 CFR Part 63, Subpart ZZZZ) were proposed on December 19, 2002: promulgated on June 15, 2004; and revised on: June 26, 2006; January 18, 2008; January 30, 2013; and February 27, 2014, and August 10, 2022. These regulations apply to owners and operators of a stationary reciprocating internal combustion engines (RICE) at either a major or area source of hazardous air pollutant (HAP) emissions, except if the stationary RICE is being tested at a stationary RICE test cell/stand. A stationary RICE is any internal combustion engine which uses reciprocating motion to convert heat energy into mechanical work and which is not mobile. New facilities include those that commenced construction, modification or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 63, Subpart ZZZZ. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Current amendments to the regulations mainly add electronic reporting provisions to the rule. In general, the changes do not result in regulated entities needing to submit anything additional electronically that is not currently submitted via paper copies, and this is therefore expected to lessen recordkeeping and reporting burden. This supporting statement addresses incremental information collection activities that will be imposed by the amendments to the NESHAP for Stationary Reciprocating Internal Combustion Engines.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC Sec. 7401 et seq.	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Pesticides Data Call In Program (Renewal)

Key Information

Abstract

This ICR covers the information collection (IC) activities associated with the issuance of data-call-ins (DCIs) under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) , both as amended by the Food Quality Protection Act (FQPA) of 1996. In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements. FIFRA also requires EPA to assess whether the continued registration of a pesticide causes unreasonable adverse effects on human health or the environment and to decide whether to pursue appropriate regulatory measures. EPA uses the DCIs issued under this ICR to acquire the data necessary to support registration review. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with the use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate whether a pesticide has the potential to cause harmful effects to human health and the environment, including effects to non-target organisms, federally threatened and endangered (listed) species, and to surface water or ground water. Through a rigorous scientific and public process, EPA specifies the kinds of data and information necessary to make regulatory judgments about the risks and benefits of pesticide products under FIFRA section 3, 4 and 5, as well as the data and information needed to determine the safety of pesticide chemical residues under FFDCA section 408. The regulations in 40 CFR part 158 describe the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process (e.g., as used in the registration review program); or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. As described in 40 CFR 158.30, however, FIFRA provides EPA with flexibility to require, or not require, data and information for the purposes of making regulatory judgments for individual pesticide products, thereby allowing for the data required to be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. EPA may, therefore, require the submission of additional data or information beyond that specified in the regulations if such data or information are needed to evaluate a pesticide product as required by FIFRA and FFDCA. This ICR describes how DCIs are issued and presents the Agency’s estimates of the information collection burden and costs associated with issuing DCIs.

Federal Register Notices

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

Authorizing Statutes

21 USC 346a	View Law

7 USC 136 et seq.	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

10 CFR 4, Nondiscrimination in Federally Assisted Commission Programs

Key Information

Abstract

All recipients of Federal financial assistance from the NRC are subject to the provisions of 10 CFR Part 4, “Nondiscrimination in Federally Assisted Programs or Activities Receiving Assistance from the Commission.” Respondents must notify participants, beneficiaries, applicants, and employees of nondiscrimination practices and keep records of Federal financial assistance and of their own self-evaluations of policies and practices. NRC Form 781, “SBCR Compliance Review” is a required form that should be submitted by the recipient upon initiation or modification of a program, during the pre-award and post-award stage, periodic monitoring, and, if a complaint is being processed during the pre-award application phase and upon request from an authorized NRC official during the post-award review phase. This information is necessary for determining whether any persons are or will be denied such services provided by the primary funding recipient on the basis of prohibited discrimination. In the event that discrimination is alleged in NRC- conducted and Federal financially assisted programs and activities, it may be reported using NRC Form 782.

Federal Register Notices

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

Authorizing Statutes

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

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Safe Management of Recalled Airbags (Renewal)

Key Information

Abstract

Information collection activities include maintaining at the airbag handler for no less than three years records of (1) all off-site shipments and (2) confirmations of receipt of airbag waste. The collection of information is necessary in order to ensure that the hazardous waste airbag modules and airbag inflators exempted under this rule are safely disposed of and that defective airbag modules and airbag inflators are not reinserted into vehicles where they would pose an unreasonable risk of death or serious injury.

Federal Register Notices

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

Authorizing Statutes

42 USC 3001-3004	View Law

42 USC 3006, 3010, 3017	View Law

42 USC 2002	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Certification and Compliance Requirements for Nonroad Spark-ignition Engines (Renewal)

Key Information

Abstract

This information collection is requested under the authority of Title II of the Clean Air Act (42 U.S.C. 7521 et seq.) Under this Title, EPA is charged with issuing certificates of conformity for those engines which comply with applicable emission standards. Such a certificate must be issued before engines may be legally introduced into commerce. To apply for a certificate of conformity, manufacturers are required to submit descriptions of their planned production line, including detailed descriptions of the emission control system, and test data. This information is organized by engine family groups expected to have similar emission characteristics. The emission values achieved during certification testing may also be used in the Averaging, Banking, and Trading (ABT) Program. The program allows manufacturers to bank credits for engine families that emit below the standard and use the credits for families that emit above the standard. They may also trade banked credits with other manufacturers. Participation in the ABT program is voluntary. Different categories of spark-ignition engines may also be required to comply with production-line testing (PLT) and in-use testing. There are also recordkeeping and labeling requirements. This information is collected electronically by the Gasoline Engine Compliance Branch (GECB), Implementation, Analysis and Compliance Division, Office of Transportation and Air Quality (OTAQ), Office of Air and Radiation of the U.S. Environmental Protection Agency. GECC uses this information to ensure that manufacturers comply with applicable regulations and the Clean Air Act (CAA). It may also be used by the Office of Enforcement and Compliance Assurance (OECA) and the Department of Justice for enforcement purposes. Non-CBI may be disclosed on OTAQ's Web site or upon request under the Freedom of Information Act (FOIA) to trade associations, environmental groups, and the public. Any information submitted for which a claim of confidentiality is made is safeguarded according to EPA regulations at 40 CFR 2.201 et seq.

Federal Register Notices

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

Authorizing Statutes

42 USC 7521	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

NSPS for Flexible Vinyl and Urethane Coating and Printing (40 CFR part 60, subpart FFF) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for Flexible Vinyl and Urethane Coating and Printing were promulgated on June 29, 1984; and amended on October 17, 2000. These regulations apply to facilities with rotogravure printing lines used to either print or coat flexible vinyl or urethane products for which construction, modification or reconstruction commenced after January 18, 1983. This information is being collected to assure compliance with 40 CFR Part 60, Subpart FFF. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to the NSPS.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq.	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

NESHAP for Secondary Aluminum Production (40 CFR part 63, subpart RRR) (Renewal)

Key Information

Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Secondary Aluminum Production (40 CFR Part 63, Subpart RRR) were promulgated on March 23, 2000; and amended on the following dates: December 30, 2002 (67 FR 79808); September 3, 2004 (69 FR 53980); October 3, 2005 (70 FR 57513); December 19, 2005 (70 FR 75320); September 18, 2015 (80 FR 56700); and June 13, 2016 (81 FR 38085). These regulations apply to existing facilities and new facilities that are secondary aluminum production facilities and major sources of hazardous air pollutants (HAP) either commencing construction, or reconstruction, after the date of proposal. This includes facilities that operate aluminum scrap shredders, thermal chip dryers, scrap dryers/delacquering kilns/decoating kilns, group 1 furnaces, group 2 furnaces, sweat furnaces, dross only furnaces, rotary dross coolers, and secondary aluminum processing units (SAPUs). The SAPUs include group 1 furnaces and in-line fluxers. The regulations also apply to secondary aluminum production facilities that are area sources of HAP only with respect to emissions of dioxins/furans (D/F) from thermal chip dryers, scrap dryers/delacquering kilns/decoating kilns, group 1 furnaces, sweat furnaces, and SAPUs. New facilities include those that commenced either construction, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 63, Subpart RRR.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

5-Star Safety Ratings Label Quantitative Concept Testing

Key Information

Abstract

This information collection request (ICR) requests approval for four new information collections that will be used by the National Highway Traffic Safety Administration (NHTSA) to conduct a one-time study to collect information to enhance the usefulness of vehicle safety rating information and guide the potential redesign of the Government 5-Star Safety Ratings section of the Monroney label (vehicle window sticker). The information collections include a screener questionnaire, an information collection to qualitative feedback to improve its quantitative survey instrument, and the quantitative survey. The information collected will allow NHTSA and the New Car Assessment Program (NCAP) to fulfill a congressional mandate to improve highway traffic safety. As NCAP is responsible for providing consumers with important safety information that will assist them in their vehicle purchase decisions, this research will be used to gather data to enhance the usefulness of that safety rating information and guide the potential redesign of the Government 5-Star Safety Ratings section of the Monroney label (vehicle window sticker) accordingly.

SPD-15 Implementation	Yes

Federal Register Notices

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

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Study of Warning Devices for Stopped Commercial Motor Vehicles

Key Information

Abstract

FMCSA is seeking Office of Management and Budget (OMB) approval of a new information collection entitled “Study of Warning Devices for Stopped Commercial Motor Vehicles.” Participation in the study is voluntary, so in the event of participation, no small business will have an imposed burden that it is not willing to bear. Information collection activities are planned for an 18-month period. Parked or disabled commercial motor vehicles (PDCMVs) on the road negatively impact traffic operations and safety. FMCSA requires specific warning devices to be carried on all commercial motor vehicles (CMVs) and, except in the case of necessary traffic stops, be deployed near the vehicle whenever it is stopped on the road or shoulder. Advances in automated driving system (ADS) technology have raised critical questions regarding potential barriers to regulatory compliance with warning device safety standards and regulations which reference a “driver.” Alternative types of warning devices developed by industry, including those intended to increase driver safety during device deployment, have resulted in multiple applications for exemption from the corresponding safety regulations. These recent issues related to warning device requirements also call attention to unresolved questions of how and to what extent the use of such devices improves traffic safety. Given the increasing focus on ADS, questions surrounding the safety of CMV drivers when deploying warning devices, and the availability of new technology and alternative devices, there is a need to thoroughly evaluate the use of warning devices under current regulations. FMCSA has established a contract with Virginia Tech Transportation Institute (VTTI) to collect the information associated with this ICR. Under indirect oversight of an FMCSA Contracting Officer’s Representative, experienced VTTI research staff will perform all data collection activities described in this ICR. The findings will contribute to safety by ensuring that FMCSA’s decisions and regulations are data-driven and based on safety. FMCSA’s purpose for collecting this information is to develop an understanding of whether and to what extent the deployment of warning devices near a stopped commercial motor vehicle affects the driving behavior of passing motorists, and those elements of driving behavior which have the potential to influence the likelihood of a crash involving the stopped vehicle.

Federal Register Notices

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

Authorizing Statutes

49 USC 504	View Law

49 USC 31133	View Law

49 USC 31136	View Law

49 USC 31502	View Law

49 USC 31108	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Survey of Airman Satisfaction with Aeromedical Certification Services

Key Information

Abstract

• The survey will be available for completion electronically. • The collection is reported by survey and is voluntary. • Airmen who have sought a medical certification within two years of the survey administration will be invited to participate in the survey. • The survey will take place approximately every two years. • The survey will be administered by the Safe Operations in Aerospace Research (SOAR) Laboratory of the Civil Aerospace Medical Institute with the support of Cherokee Federal. • Demographic information will be collected from respondents, but any information disseminated to the public will be presented in aggregate form. • The information obtained from the survey will be used to brief the Federal Air Surgeon, the Regional Flight Surgeons, and the Director of the Civil Aerospace Medical Institute following the survey closing. • Data will be used by the senior managers of the Office of Aerospace Medicine (OAM) to: (a) evaluate stakeholder satisfaction with aeromedical certification services provided by or on behalf of the FAA; (b) identify areas in which improvements in service delivery can be made; and (c) assess changes in stakeholder satisfaction as a result of those improvements. • All publications would provide data in aggregate (e.g., a technical report or journal article). • The information from the survey will also be briefed in the Federal Air Surgeon’s Medical Bulletin. • It is anticipated that the information collected will be disseminated to the public or used to support publicly disseminated information. As explained in the preceding paragraphs, the information gathered has utility. OAM will retain control over the information and safeguard it from improper access, modification, and destruction, consistent with OAM standards for privacy of information. See response to Question 10 of this Supporting Statement for more information on the OAM guarantee of privacy. Prior to dissemination, the information will be subjected to quality control measures and a pre-dissemination review per Section 515 of Public Law 106-554.

Federal Register Notices

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

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

Key Information

Abstract

This information collection supports information collection requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.

Federal Register Notices

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

Authorizing Statutes

21 USC 301 et. seq.	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza

Key Information

Abstract

Interim final rule amending regulations related to conditions for payment of indemnity and compensation for highly pathogenic avian influenza claims. Amendments include new activities related to biosecurity audits and instrument for conducting same, and reconsideration process for audit results.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 107 - 171 10401-18	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)

Key Information

Abstract

Section 1862(m) of the Act (established by section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) trial and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. By providing Medicare coverage of routine costs in Category A trials, the Congress removed a financial barrier that may have discouraged beneficiaries from participating in these trials. It also gives Medicare beneficiaries the opportunity to have earlier access to new medical devices. Based on our rulemaking authority in section 1871 of the Act, we are applying the same Medicare coverage requirements and scientific and ethical standards to Medicare coverage related to Category B IDE studies/trials that would be applicable to Category A IDE studies/trials. CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in ?405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section: (1) FDA IDE approval letter. (2) IDE study protocol. (3) IRB approval letter. (4) National Clinical Trials (NCT) number. (5) Supporting materials, as needed.

Federal Register Notices

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

Authorizing Statutes

42 USC 1102	View Law

42 USC 1861	View Law

42 USC 205(a)	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

[Medicaid] Medical Necessity and Contract Amendments Under Mental Health Parity (CMS-10556)

Key Information

Abstract

The final rule amends the Medicaid and CHIP regulations to implement the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). MHPAEA is a federal law that generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder (MH/SUD) benefits from imposing less favorable benefit limitations on those benefits than on medical/surgical benefits. The final rule applies mental health parity requirements to Medicaid Managed Care Organizations (MCOs), Section 1937 Alternative Benefit Plans (ABPs), and the CHIP. The final rule also contains provisions related to the disclosure of information related to the reason for denial of reimbursement or payment for MH/SUD benefits. The text only clarifies the expectations for disclosing information concerning the denial of reimbursement or payment for MH/SUD benefits. It does not impose any new or revised third-party disclosure requirements.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 3 502	View Law

Pub.L. 110 - 343 512(b)	View Law

Pub.L. 111 - 148 2001(c)	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Facilities Transferring Oil or Hazardous Materials in Bulk -- Letter of Intent and Operations Manual

Key Information

Abstract

A Letter of Intent is a notice to the CG Captain of the Port that an operator intends to operate a facility that will transfer bulk oil or hazardous materials to or from vessels. An Operations Manual (OM) is also required. The OM establishes procedures for a facility to follow when conducting transfers and in the event of a spill. The authority for the requirements is 33 U.S.C. 1321.

Federal Register Notices

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

Authorizing Statutes

33 USC 1321	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

Confirmation of Request for Reasonable Accommodation

Key Information

Abstract

The information collection requirement is necessary to obtain and record requests for reasonable accommodation, with the intent to measure and ensure Agency compliance with 29 U.S.C. § 791, Employment of Individuals with Disabilities; E.O. 13164, Requiring Federal Agencies to Establish Procedures to Facilitate the Provision of Reasonable Accommodation; EEO MD-715, EEO Reporting Requirements for Federal Agencies.

Federal Register Notices

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

Authorizing Statutes

29 USC 791	View Law

Presidential Action: