Department of Health and Human Services March 2021 – Federal Register Recent Federal Regulation Documents

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 ``Gonococcal Isolate Surveillance Project (GISP)''. The purpose of GISP is to monitor trends in antimicrobial resistance in N. gonorrhoeae strains in the United States in order to establish a scientific basis for the selection of gonococcal therapies and to allow proactive changes to treatment guidelines before widespread resistance and failures of treatment occur.

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 CryptoNet Case Report Form. The CryptoNet Case Report Form will be used by federal, state, and local public health officials responsible for conducting interviews with reported cases of cryptosporidiosis in their jurisdiction in order to systematically assess core exposure elements and risk factors among cases of cryptosporidiosis.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG- DART) and version 1.6 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and the dates when such new standard and version update will be required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. An additional note is added to the Catalog clarifying the requirements for the submission of a simplified trial summary dataset to determine a study start date at the point of submission at the electronic gateway.

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 (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 generic clearance for the collection of quantitative data on tobacco products and communications.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Infantile Epilepsy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve proposed updates to the approved information collection project ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is publishing notice of modifications to a system of records maintained by the National Institutes of Health (NIH), ``Clinical Research: Patient Medical Records, HHS/NIH/CC,'' no. 09-25-0099. The modifications affect most sections of the System of Records Notice (SORN) and are fully explained in the ``Supplementary Information'' section of this notice.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 (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 FDA regulations requiring the declaration of color additives on animal food labels.

The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended- release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg and 20 mg.

HRSA is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act.

The Food and Drug Administration (FDA, Agency, 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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning 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 associated with current good manufacturing practice (CGMP) for drugs, finished pharmaceuticals, including medical gases, and active pharmaceutical ingredients (APIs).

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Ryan was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Ryan was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of October 18, 2020 (30 days after receipt of the notice), Mr. Ryan had not responded. Mr. Ryan's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's investigation of how consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS) product qualities and intentions to use.