Information Collection Request (ICR) Tracker

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The guidance document “Medical Device Accessories--Describing Accessories and Classification Mechanisms for Accessory Types” encourages manufacturers and other parties to utilize the “de novo request” process defined in section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of medical device accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. Under the de novo request process, manufacturers and other parties may submit a de novo requesting that FDA make a classification determination for the accessory device. The de novo must include a description of the device and detailed information and reasons for any recommended classification.

Key Information

Federal Register Notices

Authorizing Statutes

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The Health Resources and Services Administration (HRSA), Health Systems Bureau, Division of Transplantation (DoT) administers the Hospital Campaign for Organ Donation under the authority of Section 377A(a) of the Public Health Service (PHS) Act. As part of its responsibility to conduct public education and outreach to increase the number of registered organ donors, HRSA launched the Workplace Partnership for Life Hospital Campaign in 2011, with a challenge to hospitals nationwide to conduct donor education and donor registry enrollment events in their facilities and communities. The purpose of the ‘DoNation’ General Workplace Campaign is to encourage other non-medical U.S. companies to conduct activities to increase organ donor registration. These workplaces’ support of organ donation is vital to HRSA’s efforts to increase donor registrations, as expanding the program outside of medical settings will broaden the pool of potential registered organ, eye, and tissue donors. The overall purpose of collecting this information is to incentivize and reward company, workplace, and Organ Procurement Organization (OPO) participation in the campaign, and to enable HRSA to obtain outcome data. Because participating in this campaign is voluntary, it is essential for HRSA to implement a methodology to engage workplaces, make participation as easy as possible, and recognize workplaces for their efforts and accomplishments. HRSA, together with its donation community partners, developed the Activity Scorecard for the Hospital Campaign that provides suggested outreach activities for hospitals to implement and a way to gather points for achieving recognition. The ‘DoNation’ General Workplace Campaign Activity Scorecard will motivate workplaces in a similar fashion. Without the Activity Scorecard, HRSA would not be able to recognize workplaces for their extra efforts in planning donor registration activities and registering new organ, eye, and tissue donors.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices.

Key Information

Federal Register Notices

Authorizing Statutes

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Any corporation that undergoes reorganization under Regulation section 1.6043-4 with stock, cash, and other property over $100 million must file Form 1099-CAP with the IRS shareholders.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Under section 6103(a), returns and return information are confidential unless disclosure is otherwise authorized by the Code. Section 6103(c), as amended in 1996 by section 1207 of the Taxpayer Bill of Rights II, Public Law 104-168 (110 Stat. 1452), authorizes the IRS to disclose returns and return information to such person or persons as the taxpayer may designate in a request for or consent to disclosure, or to any other person at the taxpayer's request to the extent necessary to comply with a request for information or assistance made by the taxpayer to such other person. Disclosure is permitted subject to such requirements and conditions as may be prescribed by regulations. With the amendment in 1996, Congress eliminated the longstanding requirement that disclosures to designees of the taxpayer must be pursuant to the written request or consent of the taxpayer.

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Federal Register Notices

Authorizing Statutes

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Form 13285-A is used by taxpayers and external partners and stakeholders to identify meaningful taxpayer burden reduction opportunities. Employees will make the forms available at education and outreach events.

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Federal Register Notices

Authorizing Statutes

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Forms 5304-SIMPLE and 5035-SIMPLE are used by an employer to permit employees to make salary reduction contributions to a savings incentive match plan (SIMPLE IRA) described in Code section 408(p). These forms are not to be filed with IRS, but to be retained in the employers' records as proof of establishing such a plan, thereby justifying a deduction for contributions made to the SIMPLE IRA. The data is used to verify the deduction. Notice 98-4 provides guidance for employers and trustees regarding how they can comply with the requirements of Code section 408(p) in establishing and maintaining a SIMPLE Plan

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Federal Register Notices

Authorizing Statutes

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Form 14411 is to be used by individuals, businesses, practitioners and other public groups to identify systemic problems that taxpayers are encountering with IRS. This form will be submitted electronically via the IRS.gov website. Mailed or faxed forms will be accepted and are necessary.

Key Information

Federal Register Notices

Authorizing Statutes

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Form 7004 is used by corporations and certain non-profit institutions to request an automatic extension of time to file their income tax returns. The information is needed by IRS to determine whether Form 7004 was timely filed so as not to impose a late filing penalty in error and also to insure that the proper amount of tax was computed and deposited.

Key Information

Federal Register Notices

Authorizing Statutes

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Information is needed to figure and report an installment sale for a casual or incidental sale of personal property, and a sale of real property by someone not in the business of selling real estate. Data is used to determine whether the installment sale has been properly reported and the correct amount of profit is included in income on the taxpayer's return.

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Federal Register Notices

Authorizing Statutes

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This form was developed to allow a trustee of a trust or an executor of an estate to make an election under IRC section 643(g) to allocate any payment of estimated tax to a beneficiary(ies). This form serves as a transmittal so that Service Center personnel can determine the correct amounts that are to be transferred from the fiduciary's account to the individual's account.

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Federal Register Notices

Authorizing Statutes

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Form 8876 is used to report and pay the 40% excise tax imposed under section 5891 on the factoring discount of a structured settlement factoring transaction.

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Federal Register Notices

Authorizing Statutes

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This revenue procedure sets forth the procedures to be followed by individuals who wish to request permission to revoke the election they made under section 83(b).

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Federal Register Notices

Authorizing Statutes

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The Paleontological Resources Preservation Act (PRPA) was enacted to preserve paleontological resources for current and future generations because these resources are nonrenewable and are an irreplaceable part of America’s heritage. PRPA requires that implementation be coordinated between the Secretaries of the Interior and Agriculture and that DOI and USDA issue regulations as appropriate to carry out the law. We (DOI) are proposing regulations to implement the PRPA. The proposed rule would preserve, manage, and protect paleontological resources on BLM, NPS, Reclamation, and FWS lands and ensure that these resources are available for current and future generations to enjoy as part of America’s national heritage. The rule would address the management, collection, and curation of paleontological resources from Federal lands using scientific principles and expertise, including collection in accordance with permits, curation in an approved repository, maintenance of confidentiality of specific locality data, and authorization of penalties for illegal collecting, damaging, otherwise altering or defacing, or sale of paleontological resources. Information collected will allow the DOI bureaus to inventory paleontological resources, implement the permitted collection of fossils from the ground, preserve collected fossils in repositories, track and report the location and condition of paleontological resources, implement the civil penalties provisions with due process considerations, and monitor the results of scientific investigations that involve the use of paleontological resources in both the field and in museum collections.

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Federal Register Notices

Authorizing Statutes

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The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. A "Pre-Existing" tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A Pre-Existing tobacco product may also serve as the predicate tobacco product in a section 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act( 21 U.S.C. 387e(j)(1)(A)(i))). FDA interprets the phrase "as of February 15, 2007," as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007. The guidance associated with this collection of information recommends that the manufacturer submit information adequate to demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007. Examples of such information may include, but are not limited to, the following: dated copies of advertisements, dated catalog pages, dated promotional material, and dated bills of lading.

Key Information

Federal Register Notices

Authorizing Statutes

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This collection covers final regulations under section 1.860G-2 that expand the list of permitted loan modifications to include certain modifications that are often made to commercial mortgages. The collection of information in this regulation is in section 1.860G-2(b) (7). To establish that the 80-percent test is met at the time of modification, the servicer must obtain an appraisal or some other form of commercially reasonable valuation (the appraisal requirement). This information is required to show that modifications to mortgages permitted will not cause the modified mortgage to cease to be a qualified mortgage.

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Federal Register Notices

Authorizing Statutes

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Rule 15Ba2-1 provides that an application for registration by a bank municipal securities dealer must be filed on Form MSD. The information required to be disclosed on Form MSD is necessary for the Commission to determine whether or not registration as a municipal securities dealer should be granted.

Key Information

Federal Register Notices

Authorizing Statutes

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Information collected with this form is used to evaluate the financial profile of OWCP beneficiaries who have been overpaid benefits, and their ability to repay. OWCP beneficiaries are typically retired coal miners disabled by black lung disease, Federal employees injured on the job, and their survivors.

Key Information

Federal Register Notices

Authorizing Statutes

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The information is required to allow HUD to conduct a competition to award and obligate Jobs Plus grant funds in accordance with the FY 2014 Appropriations Act, which permits HUD to use up to $15M of the appropriation for Jobs Plus Initiative

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The Malcolm Baldrige National Quality Improvement Act of 1987, Public Law 100-107, established an annual U.S. National Quality Award (Award). The purposes of the Award are to promote competitiveness and quality awareness, recognize the performance achievements of U.S. companies, and to share successful strategies and practices.