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

HRSA announces a request for comments and notice of a public meeting to receive feedback on proposed updates to the list of testing services and scores for foreign health care workers to demonstrate English language proficiency pursuant to section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly related to embryo-fetal development (EFD)) for anticancer pharmaceuticals and to provide recommendations to applicants for pharmaceutical labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. The guidance also clarifies FDA's current thinking on when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). The intended outcome of this guidance is to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles, and to provide a consistent approach to labeling recommendations for the duration of contraception after completion of therapy. This guidance finalizes the guidance of the same name issued September 29, 2017.

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

The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the State Temporary Assistance for Needy Families (TANF) Case Studies project. This study seeks to document innovative employment and training programs for low- income individuals including TANF recipients and examine the ways the programs provide or link families to wraparound services. Over a three- year period, the study will conduct up to 12 comprehensive qualitative case studies and up to 20 profiles of innovative programs to showcase promising approaches.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces that, effective immediately, it is temporarily suspending the importation of dogs from Egypt. This includes dogs originating in Egypt that are imported from third-party countries if the dogs have been present in those countries for less than six months. CDC is taking this action in response to an increase of imported cases of rabies in dogs from Egypt. This action is needed to prevent the reintroduction of canine rabies virus variant (CRVV), which has been eliminated from the United States. This suspension will remain in place until appropriate veterinary controls have been established in Egypt to prevent the export of rabid dogs. CDC will coordinate with other federal agencies and entities as necessary to implement this action.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.

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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Progress and Monitoring Report (PPMR). This collection of information assists CDC in being responsible for the stewardship of funds provided via contracts, grants, and cooperative agreements, from CDC to partners throughout the world, while providing excellent, professional services to our partners and stakeholders.

The Department of Health and Human Services (HHS) is updating a portion of one office, the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary (OS). ASFR is modifying its structure to streamline and improve operational functionality by replacing the Office of Grants and Acquisition Policy and Accountability (AMT) and establishing in its place the Office of Acquisitions (AMV), and the Office of Grants (AMU).

The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) meeting has been rescheduled due to unforeseen circumstances and will now be held on Tuesday, July 2, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACBSCT website at https:// bloodcell.transplant.hrsa.gov/about/advisory_council/meetings / index.html.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by CooperVision, Inc., proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Medical X- Ray Imaging Devices Conformance with IEC Standards.'' This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the 2019 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update cruise industry representatives and other interested persons on work completed in 2018 and plans for future activities. HHS/CDC is also opening a public docket so that written comments and materials regarding VSP's 2018 and future work may be submitted. The official record of this meeting will remain open through July 26, 2019, so that comments related to the topics discussed at the meeting may be submitted and made part of the record.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).'' This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.