Department of Health and Human Services March 20, 2017 – Federal Register Recent Federal Regulation Documents

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
Document Number: 2017-05526
Type: Rule
Date: 2017-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding ``intended uses'' and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to ``intended uses'' generally.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
Document Number: 2017-05491
Type: Rule
Date: 2017-03-20
Agency: Department of Health and Human Services
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' The January 5, 2017 final rule sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This interim final rule delays the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. Commenters are also invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-05419
Type: Notice
Date: 2017-03-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop; Correction
Document Number: 2017-05417
Type: Notice
Date: 2017-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, December 29, 2016. The document announced a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The document was published with an error in the Web site address to access the transcript of the workshop. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals
Document Number: 2017-05415
Type: Notice
Date: 2017-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the submission of reports of corrections and removals that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Document Number: 2017-05414
Type: Notice
Date: 2017-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Voluntary National Retail Food Regulatory Program Standards.