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Zdrowie i gospodarka · 20.09.2010

340B Drug Pricing Program Manufacturer Civil Monetary Penalties

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992" enacted Section 340B of the Public Health Service Act (PHSA). Section 340B implements a drug pricing program by which manufacturers enter into an agreement to sell covered outpatient drugs to particular covered entities at a price not exceeding the amount determined under a statutory formula. Manufacturers are required by section 1927(a) of the Social Security Act to enter in agreements with the Secretary that comply with section 340B if they participate in the Medicaid Drug Rebate Program. Section 7102(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) requires the Secretary of HHS to develop and issue regulations for the 340B Drug Pricing Program (340B Program) establishing standards for the imposition of sanctions in the form of civil monetary penalties for manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug. As HHS never has had civil monetary penalty authority that addresses manufacturing overcharging of the 340B Program, these regulations present a number of issues that have the potential to impact stakeholders. Accordingly

Source: Federal Register — Health and Human ServicesOpen original release →
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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Crisis Response (PHCR) Cooperative Agreement. The Public Health Crisis Response (PHCR) Cooperative Agreement provides rapid funding to help existing public health programs respond to major public health emergencies and crises.

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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Respiratory Protective Devices--42 CFR 84. The purpose of this data collection is to enable 42 CFR part 84 respirator approval certification activities.

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Zdrowie i gospodarka · 9/28/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Emergency Preparedness (PHEP) Cooperative Agreement. This request proposes to collect information from the PHEP Cooperative Agreement awardees to document and monitor their performance measure progress and fulfillment.

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