Information Collection Request (ICR) Tracker

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Federal Register Notices

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This collection of information is required by the provisions of the Patent Cooperation Treaty (PCT), which became operational in June 1978 and is administered by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland. The provisions of the PCT have been implemented by the United States in Part IV of Title 35 of the U.S. Code (Chapters 35-37) and Subpart C of Title 37 of the Code of Federal Regulations (37 CFR 1.401-1.499). The purpose of the PCT is to provide a standardized filing format and procedure that allows an applicant to seek protection for an invention in several countries by filing one international application in one location, in one language, and paying one initial set of fees. The information in this collection is used by the public to submit a patent application under the PCT and by the United States Patent and Trademark Office (USPTO) to fulfill its obligation to process, search, and examine the application as directed by the treaty. The filing, search, written opinion, and publication procedures are provided for in Chapter I of the PCT. Additional procedures for a preliminary examination of PCT international applications are provided for in optional PCT Chapter II. Under Chapter I, an applicant can file an international application in the national or home office (Receiving Office (RO)) or the IB. The USPTO acts as the United States Receiving Office (RO/US) for international applications filed by residents and nationals of the United States. These applicants send most of their correspondence directly to the USPTO, but they may also file certain documents directly with the IB. The USPTO serves as an International Searching Authority (ISA) to perform searches and issues an international search report (ISR) and a written opinion on international applications. The USPTO also issues an international preliminary report on patentability (IPRP Chapter II) when acting as an International Preliminary Examining Authority (IPEA). The RO reviews the application and, if it contains all of the necessary information, assigns a filing date to the application. The RO maintains the home copy of the international application and forwards the record copy of the application to the IB and the search copy to the ISA. The IB maintains the record copy of all international applications and publishes them 18 months after the earliest priority date, which is the earliest date for which a benefit is claimed. The ISA performs a search to determine whether there is any prior art relevant to the claims of the international application and will issue an international search report and written opinion as to whether each claim is novel, involves an inventive step, and is industrially applicable. The ISA then forwards the international search report and written opinion to the applicant and the IB. The IB will normally publish the application and search report 18 months after the priority date, unless early publication is requested by the applicant. Until international publication, no third person or national or regional office is allowed access to the international patent application unless so requested or authorized by the applicant. If the applicant wishes to withdraw the application (and does so before international publication), international publication does not take place. Under Chapter II of the Treaty, an applicant who has filed an international application in an RO can demand an international preliminary examination of the application by an IPEA, such as the USPTO. The Demand is made separately from the international application and contains prescribed particulars, language, and form. The International preliminary examination is a second evaluation of the potential patentability of the claimed invention, using the same standards on which the written opinion of the ISA was based. A copy of the examination report is sent to the applicant and to the IB.

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Federal Register Notices

Authorizing Statutes

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The United States and several other countries have undertaken to increase the effectiveness of their respective controls over international trade in strategic commodities by means of an import Certificate procedures. For the U.S. importer, this procedure provides that, where required by the exporting country with respect to a specific transaction, the importer certifies to the U.S. Government that he/she will import specific commodities into the United States and will not reexport such commodities except in accordance with the export control regulation of the United States. The U.S. Government, in turn, certifies that such representations have been made.

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Federal Register Notices

Authorizing Statutes

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The U.S. Department of Education is requesting approval for an extension without change for the Application for Assistance under Section 7003 of Title VIII of the Elementary and Secondary Education Act (ESEA) as amended by the Every Student Succeeds Act (ESSA). This application is for a grant program otherwise known as Impact Aid Basic Support Payments. Local Educational Agencies (LEAs) whose enrollments and revenues are adversely impacted by Federal activities use this form to request financial assistance. Regulations for the Impact Aid Program are found at 34 CFR §222. The statute and regulations for this program require a variety of data from applicants annually to determine eligibility for the grants and the amount of grant payment under the statutory formula. The least burdensome method of collecting this required information is for each applicant to submit these data through a web-based electronic application hosted on the Impact Aid Grant System (IAGS) website.

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Federal Register Notices

Authorizing Statutes

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the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA), a qualifying single source drug that meets the requirements for the exception for small biotech drugs (“Small Biotech Exception”) in section 1192(d)(2) of the Social Security Act (the Act) will be excluded from the definition of “negotiation-eligible drug” with respect to initial price applicability years 2026, 2027, and 2028. Among other requirements for this exception, the statute requires that CMS consider, for Part D drugs, total 2021 Medicare expenditures for the drug under Part D; total expenditures for all covered Part D drugs for such year; and total expenditures under Part D for all covered Part D drugs for which the manufacturer has an agreement under section 1860D-14A during 2021. For the purpose of this information collection request, “controlled group” means all corporations or partnerships, proprietorships and other entities treated as a single employer under 26 U.S. Code section 52(a) or (b). In order to accurately identify, at the request of a manufacturer, whether a given covered Part D drug qualifies for the Small Biotech Exception in accordance with section 1192(d)(2) of the Act, CMS needs to collect information to identify the entity that had a Medicare Coverage Gap Discount Program Agreement under section 1860D-14A for the drug as of December 31, 2021,including all other entities that, as of December 31, 2021, were treated as a single employer with that entity under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986.

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This ICR package is a renewal of an existing collection, Recordkeeping and Reporting for the Renewable Fuel Standard Program, OMB Control Number 2060-0725, expiring August 31, 2022. The RFS regulations are in 40 CFR part 80, subpart M. Because it is more efficient and easier for regulated parties to understand, we seek to consolidate the following approved ICRs into this collection: Modifications to Fuel Regulations to Provide Flexibility for E15; Modifications to RFS RIN Market Regulations (Final Rule), OMB Control Number 2060-0723, expiring November 30, 2022; and Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021, Response to the Remand of the 2016 Standards, and Other Changes (Final Rule), OMB Control Number 2060-0728, expiring December 31, 2023. The RFS program was created under the Energy Policy Act of 2005 (EPAct), which amended the Clean Air Act (CAA). The Energy Independence and Security Act of 2007 (EISA) further amended the CAA by expanding the RFS program. The RFS program is a national policy that requires a certain volume of renewable fuel to replace or reduce the quantity of petroleum-based transportation fuel, heating oil or jet fuel. The reporting requirements of the RFS program typically fall under registration and compliance reporting. Recordkeeping requirements include product transfer documents (PTDs) and retention of records that support items reported. Because RFS relies upon a marketplace of RINs, EPA has created and maintains the EPA Moderated Transaction System (EMTS) capable of handling a high volume of RIN trading activities. The respondents to this ICR are RIN Generators (producers and importers of renewable fuel), Obligated Parties (refiners and importers of gasoline and diesel), Exporters, RIN Owners, independent third-party Quality Assurance Plan (QAP) Providers, Third Parties (Auditors who submit reports on behalf of other respondents), and certain petitioners under the international aggregate compliance approach (such petitions are infrequent).

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Authorizing Statutes

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Patent applications that contain nucleotide and/or amino acid sequence disclosures must include a copy of the sequence listing in accordance with the requirements in 37 CFR 1.821-1.825. Applicants submit copies of sequence listings for both U.S. and international biotechnology patent applications. The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application. The USPTO also uses the sequence listings to support publication of patent applications and issued patents. Sequence listings are searchable after publication. This information collection covers the submission of the sequence listing information itself. Information pertaining to the filing of the initial U.S. patent application is collected under OMB Control Number 0651-0032, and information pertaining to the filing of the initial international application is collected under OMB Control Number 0651-0021. In particular, this information collection accounts for sequence listings submitted on paper, compact disc (CD), or through EFS-Web, the USPTO’s online filing system. Sequence listings may be submitted via EFS-Web as an ASCII text file or in Portable Document Format (PDF). For U.S. applications, § 1.821(c) permits all modes of submission: paper, CD, or EFS-Web. Sequence listings for international applications may be submitted on paper or through EFS-Web only, though sequence listings that are too large to be filed electronically though EFS-Web may be submitted on CD. This information collection also accounts for the requirement under § 1.821(e) that a copy of the sequence listing required by § 1.821(c) be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824. Under §§ 1.821(e)–(f), applicants who submit their sequence listings on paper, CD, or as a PDF via EFS-Web must submit a copy of the sequence listing in CRF with a statement indicating that the CRF copy of the sequence listing is identical to the paper, CD, or PDF copy provided under § 1.821(c). Applicants may submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable media as provided in § 1.824. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of §§ 1.824(a)(2)–(6) and (b), and applicant has not filed a sequence listing on paper, CD or as a PDF file, the text file will serve as both the copy required by § 1.821(c) and the CRF required by § 1.821(e). Moreover, the associated statement of identity would not be required. This information collection also covers the mechanism in § 1.821(e) where an applicant may request, in limited circumstances, a transfer of the CRF from the application already on file to the new application, if the CRF sequence listing in a new application is identical to the CRF sequence listing of another application that the applicant already has on file at the USPTO. In such a case, the applicant may submit a letter identifying the application and CRF sequence listing that is already on file and stating that the sequence listing submitted in the new application is identical to the CRF copy already filed with the previous application. The USPTO provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.

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Federal Register Notices

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The purpose of this survey is to assess the workplace climate and evaluate the prevalence of harassment and discrimination at the National Institutes of Health (NIH). Specifically, the results of this survey will facilitate a data-driven analysis of the types of harassment and/or discrimination that may be occurring or is perceived to be occurring, by its workers. To this end, where applicable, NIH will leverage these findings to identify areas within NIH that require further investigation, thereby providing opportunities for targeted prevention or mitigation strategies.

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The Indian Gaming Regulatory Act directs the National Indian Gaming Commission to monitor class II gaming conducted on Indian lands on a continuing basis in order to ensure that the Indian tribe is the primary beneficiary of the gaming operation and to protect such gaming as a means of generating tribal revenue, and to assure that gaming is conducted fairly and honestly by both the operator and players. The Commission has established minimum internal control standards to aid it in monitoring class II gaming on a continuing basis.

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Federal Register Notices

Authorizing Statutes

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Rule of Practice 194 provides a process for a registered security-based swap dealer or major security-based swap participant to make an application to the Commission for an order permitting an associated person that is a natural person who is subject to a statutory disqualification to effect or be involved in effecting security-based swaps on behalf of the security-based swap dealer or major security-based swap participant.

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DoD is extending information collections requirements under current OMB Control Number 0720-0032. Pharmaceutical manufacturers will base refund calculation on difference between average non-Federal price of drug sold by pharmaceutical manufacturer to wholesalers, represented by most recent annual non-Federal average manufacturing prices (non-FAMP) and corresponding Federal Ceiling Price (FCP) or, at discretion of pharmaceutical manufacturer, difference between FCP and direct commercial contract sales price attributable to applicable National Drug Code.

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The Drug Enforcement Administration collects information regarding mail order transactions conducted between a person regulated by the agency and a nonregulated person (that is, someone who does not further distribute the product) involving the chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Transactions must use, or attempt to use, the United States Postal Service or any private or commercial carrier. This collection of information is mandated by 21 U.S.C. 830(b)(3), and permits the agency to monitor the distribution of ephedrine, pseudoephedrine and phenylpropanolamine, chemicals which are subject to diversion for the illicit manufacture of methamphetamine.

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The DEA collects information in regards to reporting and recordkeeping for digital certificates. The application for a digital certificate is required to ensure that the person applying for the certificate is either a DEA registrant or someone who has power of attorney from a DEA registrant to sign orders for Schedule I and II substances. The DEA Certification Authority uses the information to verify the person’s identity and eligibility to hold a DEA-issued digital certificate.

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Rule 18a-2 establishes net capital standards and requirements for nonbank firms required to register with the SEC under the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 as major security-based swap participants.

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Authorizing Statutes

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The Certification of Qualifying State Relief from Disabilities Program — ATF Form 3210.12 is used by a State official to certify to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) that it has established a qualifying mental health relief from firearms disabilities program that satisfies certain minimum criteria established by the NICS Improvement Amendment Act of 2007 (NIAA), Public Law 110-180.

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The Office of Trade Adjustment Assistance is charged with the administration of the Trade Adjustment Assistance for Workers program by Section 249A of the Trade Act of 1974, as amended (Act). One of the principal functions of OTAA is the investigation of Petitions for Trade Adjustment Assistance filed under Section 221 of the Act. Under the Act, OTAA is required to render determinations on petitions within 40 days of their filing.

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