Department of Health and Human Services May 9, 2019 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on Draft Toxicological Profiles for Dinitrophenols, 2-Butanone, Mirex and Chlordecone, 1,2- Diphenylhydrazine, 1,2,3-Trichloropropane, Lead, and Endrin. ATSDR has updated these profiles based on availability of new health effects information since their initial release. On March 21, 2016 ATSDR announced that it was preparing to develop Draft Toxicological Profiles for public comment release (81 FR 15110), which include those profiles mentioned above. All toxicological profiles issued as ``Drafts for Public Comment'' represent the result of ATSDR's evidence-based evaluations to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of dinitrophenols, 2-butanone, mirex and chlordecone, 1,2- diphenylhydrazine, 1,2,3-trichloropropane, lead, and endrin for review and potential inclusion in the profiles. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.'' This draft guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of their regulatory submissions to provide certain information to FDA so that FDA can internally track the submissions. The purpose of this guidance is to provide instructions on how to document that a submission includes RWE.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postapproval Pregnancy Safety Studies.'' When finalized, the purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA (i.e., pregnancy safety studies). This draft guidance, when finalized, will represent the current thinking of FDA on postapproval pregnancy safety studies. This draft guidance is intended to help industry develop more comprehensive and scientifically sound studies to assess the safety of drug and biological products during pregnancy in the postmarketing setting. The previous guidance for industry entitled ``Establishing Pregnancy Exposure Registries,'' issued on August 23, 2002, has been withdrawn.