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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.'' This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). Early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients. This guidance finalizes the draft guidance entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs'' issued on December 13, 2019, and finalizes certain material related to implementation of FDARA that was included in the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers'' issued on January 16, 2020. Accordingly, FDA does not intend to finalize the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers,'' which is now withdrawn.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) reapprove the proposed information collection project ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.''

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Lyell Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.

National Institute of Diabetes and Digestive and Kidney Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Kantum Pharma Inc. (Kantum), located in Boston, Massachussets.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry (GFI) #171 entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media.'' This guidance describes how the Agency intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages.'' This guidance describes the Agency's policy regarding the prohibition against providing National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and device packages set forth in FDA regulations. As described in the guidance, FDA does not intend to object to the use of FDA legacy identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023. The guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

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 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 recommended labeling of certain beers subject to our labeling jurisdiction.

The Health Profession Opportunity Grants (HPOG) Program provides healthcare occupational training for Temporary Assistance for Needy Families recipients and other low-income people. The Office of Management and Budget (OMB) has approved various data collection activities for the National and Tribal Evaluation of the 2nd Generation of HPOG (HPOG 2.0 National and Tribal Evaluation) under OMB #0970-0462. Due to the profound effects the COVID-19 pandemic has had on the U.S. economy, on families nationwide and on HPOG 2.0 programs, the Office of Planning, Research, and Evaluation (OPRE) is considering surveying study participants who applied to the HPOG Program after the onset of the pandemic. This notice provides a summary for public review and comment of the use and burden associated with a new information collection for this ``COVID Cohort'' Survey.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the State Performance Report. This notice solicits comments on the new information collection requirements relating to the State Performance Report.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Implanted Brain- Computer Interface (BCI) Devices for Patients with Paralysis or AmputationNon-Clinical Testing and Clinical Considerations.'' Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards (IRBs) entitled ``Frequently Asked QuestionsStatement of Investigator (Form FDA 1572) (Revision 1).'' This draft guidance partially revises the final information sheet guidance for sponsors, clinical investigators, and IRBs entitled ``Frequently Asked Questions Statement of Investigator (Form FDA 1572)'' (May 2010) (the Form FDA 1572 FAQ Guidance) to explain FDA's current thinking regarding waivers of the signature requirement for Form FDA 1572. This draft guidance proposes to revise responses to frequently asked questions 10, 11, and 13 from the Form FDA 1572 FAQ Guidance by including information regarding the waiver of the Form FDA 1572 signature requirement and proposes a new section regarding signature waivers.