Change Requests

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PBM Fee Disclosure Regulation under 408(b)(2)

Key Information

Abstract

Providers of pharmacy benefit management services (PBMs) and affiliated providers of brokerage and consulting services are required to disclose information about their compensation to fiduciaries of self-insured group health plans subject to the Employee Retirement Income Security Act (ERISA). The disclosures would assist the fiduciaries in assessing the reasonableness of the contracts or arrangements with these service providers, including the reasonableness of the services providers’ compensation. These disclosure requirements would apply for purposes of ERISA’s statutory prohibited transaction exemption for services arrangements.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

29 USC 1135	View Law

29 USC 1108	View Law

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Continuing Disability Review Report

Key Information

Abstract

Sections 221(i), 1614(a)(3)(H)(ii)(I) and 1633(c)(1) of the Social Security Act (Act) require SSA to periodically review the cases of individuals who receive benefits under Title II or Title XVI based on disability to determine if their disability continues. SSA considers adults eligible for disability payments if they continue to be unable to do substantial gainful activity because of their impairments, and we consider Title XVI children eligible for disability payment if they have marked and severe functional limitations because of their impairments. To assess claimants’ ongoing disability payment eligibility, SSA uses the information gathered through the Continuing Disability Review Report to complete a mandatory review for the continue disability review (CDR). SSA also uses the Continuing Disability Review Report to obtain information on sources of medical treatment; participation in vocational rehabilitation programs (if any); attempts to work (if any); and recipients’ assessments when they believe their conditions improved. Title II or Title XVI disability recipients can complete the Continuing Disability Review Report using one of three modalities: (1) a paper application or fillable PDF (using Form SSA 454 BK); (2) a field office interview, during which SSA employees enter claimant’s data directly into the Electronic Disability Collection System (EDCS); or (3) using an online system (i454). This new web-based modality will provide recipients a new platform for submitting information to increase accessibility and enhance automation. When SSA initiates a medical CDR, we send a mailed notice to the individual with a disability informing that individual that SSA requires a CDR. The mailed notice provides instructions to the recipient on how to assist the agency with initiating the CDR and gives the individual the option to complete a paper SSA-454 or an i454 for adult only disabled individuals. When an individual requires a CDR, a claims specialist (CS) mails the paper Form SSA-454-BK, and the respondent completes the form, and sends or brings it back to SSA; or the CS interviews the respondent and enters the information into the appropriate EDCS screens; or adult disabled individuals complete the SSA 454 BK electronically using the i454 Internet application. Regardless of the modality the respondent uses to complete the information (paper, EDCS, or Internet versions), SSA electronically stores the information provided in EDCS. The respondents complete the SSA-454-BK by themselves with self-help information available, or a representative may complete the paper form or electronic application on their behalf. The respondents are Title II or Title XVI disability recipients or their representatives.

Federal Register Notices

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

Authorizing Statutes

42 USC 421	View Law

42 USC 405	View Law

42 USC 423	View Law

42 USC 1382c	View Law

42 USC 1383	View Law

42 USC 1383b	View Law

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Application and Permit to Handle Hazardous Material

Key Information

Abstract

The information is used to ensure the safe handling of explosives and other hazardous materials around port and aboard vessels. Shipping agents and terminal operators who handle the above commodities must comply. The statutory authority for the requirements is 46 U.S. Code (U.S.C.) 70011 and 70034, and 49 U.S.C. 5101-5108.

Federal Register Notices

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

Authorizing Statutes

49 USC 5102	View Law

49 USC 5103	View Law

49 USC 5101	View Law

49 USC 5103a	View Law

49 USC 5104	View Law

49 USC 5105	View Law

49 USC 5106	View Law

49 USC 5107	View Law

49 USC 5108	View Law

46 USC 70011	View Law

46 USC 70034	View Law

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Motor Vehicle Emissions and Fuel Economy Compliance (Renewal)

Key Information

Abstract

Under sections 202(a) and 202(k) of the Clean Air Act (42 U.S.C. 7521), EPA finalized regulations to set more stringent vehicle emission standards beginning in model year 2017, as part of a systems approach to addressing the impacts of motor vehicles and fuels on air quality and public health. The Tier 3 vehicle emission standards, which are the subject of this ICR, reduce both tailpipe and evaporative emissions from passenger cars, light-duty trucks, medium-duty passenger vehicles, and some heavy-duty vehicles. The Tier 3 vehicle standards are harmonized with California's Low Emission Vehicle Program LEVIII standards, creating a federal vehicle emissions program allowing automakers to sell the same vehicles in all fifty states. This ICR covers the information that affected respondents must provide to the Agency. Any information submitted to the Agency for which a claim of confidentiality is made is safeguarded according to policies set forth in CFR title 40, chapter 1, part 2, subpart B Confidentiality of Business Information (see 40 CFR part 2).

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq.	View Law

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Application for International and Domestic Indemnification

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Abstract

Applicants for federal international and domestic indemnity under the Arts and Artifacts Indemnity Act (P.L. 94-158) are required to submit indemnity applications. Respondents include non-profit, tax-exempt organizations (primarily museums).

Federal Register Notices

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

Authorizing Statutes

Pub.L. 94 - 158 1, 89 Stat. 844	View Law

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Declaration of Inspection Before Transfer of Liquid Cargo in Bulk

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Abstract

A Declaration of Inspection (DOI) is used as an instrument to document the transfer of oil and hazardous materials, to help prevent spills and damage to a facility or vessel. Persons-in-charge of the transfer operations must review and certify compliance with procedures specified by the terms of the DOI. The statutory authority is 46 U.S.C. 3703 and 70011.

Federal Register Notices

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

Authorizing Statutes

46 USC 3703	View Law

46 USC 70011	View Law

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Form for Maintenance of Effort Waiver Requests

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Abstract

Section 8521(a) of the Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act (ESEA) provides that a local educational agency (LEA) may receive funds under Title I, Part A and other ESEA “covered programs” for any fiscal year only if the State educational agency (SEA) finds that either the combined fiscal effort per student or the aggregate expenditures of the LEA and the State with respect to the provision of free public education by the LEA for the preceding fiscal year was not less than 90 percent of the combined fiscal effort or aggregate expenditures for the second preceding fiscal year. This provision is the maintenance of effort (MOE) requirements for LEAs under the ESEA. If an LEA fails to meet the MOE requirement, under section 8521(b) of the ESEA, the SEA must reduce the amount of funds allocated under the programs covered by the MOE requirement in any fiscal year in the exact proportion by which the LEA fails to maintain effort by falling below 90 percent of either the combined fiscal effort per student or aggregate expenditures, if the LEA has also failed to maintain effort for 1 or more of the 5 immediately preceding fiscal years. In reducing an LEA’s allocation because it failed to meet the MOE requirement, the SEA uses the measure most favorable to the LEA. Section 8521(c) gives the U.S. Department of Education (ED) the authority to waive the ESEA's MOE requirement for an LEA if it would be equitable to grant the waiver due to an exceptional or uncontrollable circumstance such as a natural disaster or a change in the organizational structure of the LEA or a precipitous decline in the LEA's financial resources. If an MOE waiver is granted, the reduction required by section 8521(b) does not occur for that year. A request for a waiver of the MOE requirement is discretionary. Only an LEA that has failed to maintain effort and that believes its failure justifies a waiver would request one. To review an MOE waiver request, ED relies primarily on expenditure, revenue, and other data relevant to an LEA’s request provided by the SEA. To assist an SEA with submitting this information, ED developed an MOE waiver form as part of the 2009 Title I, Part A Waiver Guidance, which covered a range of waivers that ED invited at that time. The purpose of this request is to renew approval for the MOE waiver form. This collection includes burden at the SEA level.

Federal Register Notices

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

Authorizing Statutes

20 USC 8521	View Law

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NRC Insider Threat Program for Licensees and Others Requiring Access to Classified Information

Key Information

Abstract

The NRC-regulated facilities and their contractors who are authorized to access and possess classified matter are required to provide information and maintain records to demonstrate they have established and are maintaining an Insider Threat Program to identify and protect classified information against a potential insider threat.

Federal Register Notices

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

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Application to Register Permanent Residence or Adjust Status

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Abstract

The information on Form I-485 will be used to request and determine eligibility for adjustment of permanent residence status. Supplement A is used to adjust status under section 245(i) of the Immigration and Nationality Act (Act).

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

8 USC 1255	View Law

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Alaska Interagency Electronic Reporting System (IERS)

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Abstract

The National Marine Fisheries Service (NMFS), Alaska Regional Office, requests revision of this currently approved information collection. This information collection is revised and extended due to the associated rule (RIN 0648-BL49) changing the time limit for recording a management program in the catcher/processor electronic logbook (eLog). This action revises and standardizes the time limit for assigning a management program to each haul for trawl catcher/processors (C/Ps) participating in the groundfish fisheries in the Gulf of Alaska (GOA) and the Bering Sea and Aleutian Islands (BSAI) management areas. This rule is necessary to improve consistency for when trawl C/Ps are required to assign a specific management program to a haul and will allow additional time for vessel operators participating in Western Alaska Community Development Quota (CDQ) Program and non-CDQ fisheries on the same trip to better determine which management program to assign to a haul. This revision does not change the respondents, responses, burden hours, or costs for the catcher/processor eLog because the directly regulated entities already complete this logbook, and the current burden estimate allows for differences in the time and cost needed to complete and submit the logbook.

Authorizing Statutes

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Return A-Monthly Return of Offenses known to Police and Supplement to Return A-Monthly Return of Offenses Known to Police

Key Information

Abstract

Under 34 USC 41303 and 28 USC 534, this collection requests offense data from federal, state, county, city, tribal, and territorial law enforcement agencies in order for the FBI's UCR Program to serve as the national clearinghouse for the collection and dissemination of crime data.

Federal Register Notices

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

Authorizing Statutes

28 USC 534	View Law

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Federal Fish and Wildlife Applications and Reports - Law Enforcement; 50 CFR 13 and 14

Key Information

Abstract

Section 9(d) of the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.), as amended, makes it unlawful to import or export wildlife or wildlife products for commercial purposes without first obtaining an import/export license (50 CFR Part 14.91). Persons required to obtain an import/export license must keep records that fully and correctly disclose each importation or exportation of fish, wildlife, or plants and the subsequent disposition made by them with respect to such fish, wildlife, or plants for a period of 5 years (50 CFR Part 13.46 and 14.93). Any live wildlife possessed under permit issued by the U.S. Fish and Wildlife Service (we, Service) must be maintained under humane and healthful conditions (50 CFR Part 13.41).

Federal Register Notices

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

Authorizing Statutes

16 USC 1531 et seq	View Law

16 USC 1371	View Law

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U.S. Fish and Wildlife Service Bison Donations Request Program

Key Information

Abstract

The Service’s “Bison Donations Transfer Protocol” (protocol) describes the process for the donation of the available surplus bison from the Service to eligible organizations, Tribes, or intertribal organizations as outlined in regulations at 50 CFR 30, as well as in Service Manual chapters 701 FW 5 and 701 FW 8. Surplus bison are offspring that exceed the ecological carrying capacity of the Service bison metapopulation. The primary purposes of donating these bison are to support conservation of the species as native North American wildlife and to assist in the restoration of bison herds on conservation partner lands, with special emphasis on restoring conservation herds to Tribal lands. Our authorities governing the Protocol include: • National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd and 668ee; as amended); • American Indian Religious Freedom Act of 1978 (42 U.S.C. 1996); • Indian Self-Determination and Education Assistance Act (Public Law 93-638, as amended); • Surplus Range Animals (50 CFR 30.1); • Disposition of Surplus Range Animals (50 CFR 30.2); • Native American Policy of the U.S. Fish and Wildlife Service (510 FW 1); • Collections, Donations, and Disposals policy (701 FW 5); and • Fenced Animal Management policy (701 FW 8). In 2020, the U.S. Department of the Interior (DOI) Bison Working Group published the Department of the Interior Bison Conservation Initiative 2020 (2020 initiative), recognizing bison as a wildlife species in need of conservation. Consistent with this initiative, Service policy identifies the ecological and cultural values of bison as nationally and/or historically significant animals. The Bison Conservation Genetics Workshop: Report and Recommendations (2010 report) identifies DOI bison herds as a valuable source with which to start new conservation herds proposed by other Federal, State/provincial, or Tribal governments. The DOI Bison Report: Looking Forward (2014 report) acknowledges the challenges to achieving bison restoration on DOI lands and emphasizes the importance of partnerships for achieving bison conservation and ecological restoration. Both the 2010 and 2014 reports also identify the potential for bison herds maintained by Indian Tribes to contribute to species conservation, and the Service recognizes that such bison may also support Tribal cultural rights and practices.

Federal Register Notices

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

Authorizing Statutes

16 USC 668dd & 668ee	View Law

42 USC 1996	View Law

Pub.L. 93 - 638 1	View Law

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Regulation S-AM: Limitations on Affilate Marketing

Key Information

Abstract

Regulation S-AM implements the requirements of Section 624 of the Federal Credit Reporting Act (15 U.S.C. 1681s-3) with respect to investment advisers and transfer agents registered with the Securities and Exchange Commission (“SEC”), as well as brokers, dealers and investment companies (collectively, “Covered Persons”). Section 624 and Regulation S-AM limit a Covered Person’s use of certain consumer financial information received from an affiliate to solicit a consumer for marketing purposes, unless the consumer was given notice and a reasonable opportunity and a reasonable and simple method to opt out of such solicitations. This serves the SEC’s mission in protecting investors from abuse or fraud.

Federal Register Notices

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

Authorizing Statutes

15 USC 78q, 78q-1, 78w, 78mm	View Law

15 USC 80a-30(a), 80a-37, 80b-4	View Law

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Offshore Supply Vessels -- Title 46 CFR Subchapter L

Key Information

Abstract

The OSV posting/marking requirements are needed to provide instructions to those on board of actions to be taken in the event of an emergency. The reporting/recordkeeping requirements verify compliance with regulations without CG presence to witness routine matters, including OSVs based overseas as an alternative to CG inspection. The statutory authority is 46 U.S.C. 3301, 3304 through 3308. This authority is delegated by the Secretary to the Coast Guard via the Department of Homeland Security Delegation No. 0170.1, Revision No. 01.2. (II)(92)(b).

Federal Register Notices

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

Authorizing Statutes

46 USC 3301	View Law

46 USC 3302	View Law

46 USC 3303	View Law

46 USC 3304	View Law

46 USC 3305	View Law

46 USC 3306	View Law

46 USC 3307	View Law

46 USC 3308	View Law

46 USC 3309	View Law

46 USC 3310	View Law

46 USC 3311	View Law

46 USC 3312	View Law

46 USC 3313	View Law

46 USC 3314	View Law

46 USC 3315	View Law

46 USC 3316	View Law

46 USC 3317	View Law

46 USC 3318	View Law

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Requirements for the Use of Liquefied Petroleum Gas and Compressed Natural Gas as Cooking Fuel on Passenger Vessels

Key Information

Abstract

The collection of information requires passenger vessels to have posted two placards that contain safety and operating instructions on the use of cooking appliances that use liquefied gas or compressed natural gas. Respondents are owners and operators of passenger vessels. The statutory authority is 46 U.S.C. 3306 (Navigational Rules Act of 1980) (inspected vessels) and 46 U.S.C. 4302 (recreational vessels). This authority is delegated by the Secretary to the Coast Guard via the Department of Homeland Security Delegation No. 0170.1, Revision No. 01.2. (II)(79) and (92)(b).

Federal Register Notices

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

Authorizing Statutes

46 USC 3306	View Law

46 USC 4302	View Law

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Application to Transfer and Register NFA Firearm (Tax-Paid) (ATF Form 5320.4 (“Form 4”))

Key Information

Abstract

Persons with an NFA firearm must apply to ATF for approval to transfer and register the firearm as required by the NFA (26 USC 5812). ATF Form 5320.4 ("Form 4"), is the prescribed means for submitting this application, facilitates and records the firearms transfer, and also serves as proof of registration once approved.

Federal Register Notices

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

Authorizing Statutes

26 USC 5811	View Law

26 USC 5812	View Law

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Nurse Faculty Loan Program Forms

Key Information

Abstract

The NFLP – Program Specific Data Form is a required electronic attachment within the NFLP application materials. The data provided in the form is essential for the formula-based criteria used to determine the award amount to the applicant schools. The form will collect application-related data from applicants such as the amount requested, number of students to be funded, tuition information, and projected unused loan fund balance. The NFLP-Annual Performance Report (APR) Financial Data Form is an online form that exists in the HRSA Electronic Handbooks (EHBs) Performance Report module. The NFLP-APR Financial Data Form collects outcome and financial data to capture the NFLP loan fund account activity related to financial receivables, disbursements, and borrower account data related to employment status, loan cancellation, loan repayment and collections. Participating schools will provide HHS with current and cumulative information on: (1) NFLP loan funds received, (2) number and amount of NFLP loans made, (3) number and amount of loans cancelled, (4) number and amount of loans in repayment, (5) loan default rate percent, (6) number of NFLP graduates employed as nurse faculty, and (7) other related loan fund costs and activities. The NFLP Due-Diligence Form is a required form to be completed and submitted electronically by NFLP award recipients. This form indicates that due diligence has been exercised in the cancellation of all or any remaining NFLP loan for NFLP borrowers in the event of permanent/total disability or death, or the write-off of all or any remaining payment of the NFLP loan as uncollectible/bad debt. The data provided on the form will verify the due diligence process the institution used for NFLP loan cancellations or uncollectible debt write-offs. Data collected on the due-diligence form is essential for HRSA to effectively monitor performance outcomes and verify the accuracy of the number and amount of NFLP loan funds cancelled and written off that is reported by NFLP award recipients during the Annual Performance Reporting period. The form will collect the student borrower’s unique ID, amount of loan funds cancelled/written off (principal plus interest), reason for cancellation/write-off, and institutional certification/due diligence process utilized.

Federal Register Notices

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

Authorizing Statutes

42 USC 297n-1, Section 846A	View Law

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[Medicaid] Methods for Assuring Access to Covered Medicaid Services Under 42 CFR 447.203 and 447.204 (CMS-10391)

Key Information

Abstract

CMS-2328-FC requires a transparent, data-driven process for states to document that Medicaid beneficiaries have access to services covered under the Medicaid State plan to the extent that services are available to the general population in a geographic area. To meet the requirements of the final rule, states must conduct access review monitoring plans that measure: the extent that enrollee needs are met, the availability of care and qualified providers, service utilization and payment rate comparisons. The reviews will be conducted every three years for: primary care, physician specialists, behavorial health, and pre and post natal obstetric services (including labor and delivery). As states reduce or restructure provider payment rates or receive significant numbers of complaints from providers and beneficiaires about access to care, additional services must be included in the review plan and monitored for at least 3 years. We are soliciting comments on the services required for ongoing access reviews and the timelines associated with review and monitoring activities. The final rule also requires states have mechanisms for obtaining beneficiary and provider feedback on access to care, such as hotlines, surveys, ombudsman or other equivalent mechanisms and institute corrective action procedures should access issues be discovered through the access review and monitoring processes. Finally, when considering reductions to Medicaid payment rates the final rule requires states to undertake a process that gathers input from stakesholds and relies upon the information analyzed through the data reveiws on the proposed reduction or restructuring of Medicaid service payment rates.

Federal Register Notices

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

Authorizing Statutes

42 Stat. 1902

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Provider Directory Data for Medicare Plan Finder (CMS-10906)

Key Information

Abstract

MPF is an online tool that helps Medicare beneficiaries compare and shop for MA and Part D plans. MA organizations will submit or otherwise make their plan provider directory data available to CMS/HHS in a format, manner, and timeframe determined by CMS/HHS (as specified by CMS through the technical specifications) for publication online within MPF. MPF users will use the data, including, but not limited to, the names of their current doctors, as search criteria when using MPF to shop for and compare MA plans. MPF users will access MPF via the internet. An officer of each MA organization will attest, at least annually, in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under § 422.111(m) is accurate.

Federal Register Notices

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

Authorizing Statutes

42 USC 1851(d)(1)	View Law

42 USC 1851(d)(4)(A)(vii)	View Law

42 USC 1851(d)(7)	View Law

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FDIC’s Official Sign and Advertising Requirements, False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC’s Name or Logo

Key Information

Abstract

This submission is being made in connection with a Final Rule published in the Federal Register by the Federal Deposit Insurance Corporation (FDIC). On January 29, 2026, in connection with OMB Control No. 3064-0219, the FDIC published a Final Rule for FDIC Official Signs, Advertisement of Membership, False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC’s Name or Logo. The FDIC is amending its signage requirements for insured depository institutions’ (IDIs) digital deposit-taking channels and automated teller machines (ATMs) and like devices. This Final Rule is intended to address implementation issues and sources of potential confusion raised following the adoption of signage requirements for these banking channels in 2023. The Final Rule provides additional flexibility to IDIs while also enabling consumers to better understand when they are conducting business with an IDI and when their funds are protected by the FDIC’s deposit insurance coverage. The current clearance for the collection expires on March 31, 2027. The FDIC is seeking extension, with revisions, of the ICR for a period of three years.

Federal Register Notices

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

Authorizing Statutes

12 USC 1819 (Tenth)	View Law

12 USC 1820(c)	View Law

12 USC 1818	View Law

12 USC 1828(a)	View Law

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Application to Make and Register NFA Firearm (ATF Form 5320.1 ("Form 1"))

Key Information

Abstract

Any person other than a qualified manufacturer who wishes to make and register an NFA firearm must submit a written application to ATF on a form prescribed by ATF. 26 U.S.C. § 5822. They must also identify the firearm they are making, themself as the maker, and, if an individual, must include their fingerprints and a photograph with the application. In § 479.62, ATF prescribed Form 1 (ATF form number 5320.1), Application to Make and Register a Firearm for these required purposes.

Federal Register Notices

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

Authorizing Statutes

26 USC 5821	View Law

26 USC 5822	View Law

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Mariner Cadet Training-Agreements, Compliance Reporting, and Audits

Key Information

Abstract

In accordance with its delegation of authority at 49 CFR 1.93(a), and pursuant to 46 U.S.C. 50101(a)(4), the Maritime Administration (MARAD) is charged with ensuring that the United States Merchant Marine is manned with trained and efficient citizen personnel. Furthermore, 46 U.S.C. 51322 requires MARAD to protect cadet mariners from sexual assault onboard vessels and in so doing, to set sexual assault policy and to conduct random and targeted unannounced checks of commercial vessels.

Federal Register Notices

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

Authorizing Statutes

49 USC 1.93	View Law

46 USC 50101 (a)(4)	View Law

46 USC 51322	View Law

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[NCIPC] State Unintentional Drug Overdose Reporting System (SUDORS)

Key Information

Abstract

The purpose of this information collection is to detect state and local community changes in unintentional and undetermined intent drug-related overdose mortality and provide in-depth state and local (e.g., county) information on risk factors for fatal drug overdose deaths (opioid and non-opioid). State public health departments will be funded to abstract standardized data elements from medical examiner/coroner (ME/C) reports as well as death certificates and will report this information to CDC using a web-based platform. Findings will be used to inform the selection and targeting of interventions in all 50 states and the District of Columbia. This Revision contains updates to the web-based system and new data elements.

Federal Register Notices

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

Authorizing Statutes

42 USC 301	View Law

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Warning Plans for Smokeless Tobacco Products

Key Information

Abstract

Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act), requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. This information collection--the submission to FDA of warning plans for smokeless tobacco products--is statutorily mandated. Section (b)(3)(A) of 15 U.S.C. 4402 requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” to, and approved by, FDA. The warning plans will be reviewed by FDA to determine whether the companies' plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 31 3	View Law

15 USC 4402	View Law

Presidential Action: