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

This gives notice that under Public Law 111-347 (the James Zadroga 9/11 Health and Compensation Act of 2010), as amended by Public Law 114-113, and the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, the World Trade Center Health Program Scientific/ Technical Advisory Committee, the Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 12, 2023.

The Department of Health and Human Services (HHS or the Department) is issuing this document to withdraw a legally and factually inaccurate notice and request for information published in the Federal Register on November 25, 2020, entitled ``Termination of the Food and Drug Administration's Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective.'' This notice also ends the period for submission of responses to Part II of the November 25, 2020, notice and request for information.

The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``INTUIT-PC: Improving Nonsurgical Treatment of Urinary Incontinence among women in Primary Care: Dissemination and Implementation of PCOR Evidence (U18).'' This SEP meeting will be closed to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Tobacco Product User Fees: Responses to Frequently Asked Questions.'' This draft guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.'' The existing post-approval studies final guidance, entitled ``Procedures for Handling Post-Approval Studies Imposed by PMA Order,'' was issued in June 2009. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT or Council). ACBSCT shall advise the Secretary of HHS (Secretary), through the HRSA Administrator, on the activities of the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory Program (Program).

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.'' This proposed information collection was previously published in the Federal Register on March 5, 2021 and allowed 60 days for public comment. The purpose of this notice is to allow an additional 30 days for public comment.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) of the Low Income Household Water Assistance Program (LIHWAP) Plan. OCS solicited comments in the form of the LIHWAP survey (approved under OMB #0970-0531), which was available on the LIWHAP webpage from Monday, April 19-Tuesday April 27. These comments were due prior to submission of this information collection request and have been addressed in the submission package to OMB. OCS will use information from the LIHWAP Plan to identify recipients, methods and categories for grantee expenditures, as well as to assess the effectiveness of grantee planning and compliance to terms and conditions for the LIHWAP.

In accordance with requirements of the Privacy Act of 1974, as amended, the HHS is updating an existing system of records maintained by HRSA's Bureau of Health Workforce (BHW), System No. 09-15-0037, HHS/ HRSA/BHW Scholarship and Loan Repayment Program Records. The records in the system of records are about individuals who have applied for, are receiving, or have received awards under one of BHW's scholarship and loan repayment programs, as well as individuals who indicate an interest in employment in or assignment to a medical facility located in a health professional shortage area or a medically underserved population area, incident to their participation in a BHW scholarship or loan repayment program.

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 the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER). This generic clearance request, requests approval for collection of information that encompasses general questionnaire development, pre-testing, and measurement-error reduction activities to be carried out in 2021-2024.

The National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), on behalf of the Office of Science and Technology Policy (OSTP), requests input from all interested parties on research needed to identify, analyze, monitor, and mitigate drinking water contaminants of emerging concern (DW CECs). Comments provided through this Request for Information (RFI) will inform the development of a National Emerging Contaminant Research Initiative (NECRI). The NECRI will be the precursor to Federal coordination of DW CEC research; and agencies will publish external grant solicitations that align with the goals of the NECRI.

The Food and Drug Administration (FDA, Agency, or we) 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 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under the FD&C Act. This guidance finalizes the draft guidance of the same title issued on October 3, 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' FDA developed this guidance to provide FDA's recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices.

The Food and Drug Administration (FDA or Agency) has determined that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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, the Agency, or we) is announcing the following public meeting entitled ``FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.'' The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

The Food and Drug Administration (FDA, Agency, or we) has determined that ISOPTIN (verapamil hydrochloride) tablets, 40 milligrams (mg), 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, if all other legal and regulatory requirements are met.

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 Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The National Institute of Allergy and Infectious 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 Mevox, Ltd., located in Rugby, United Kingdom.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) takes this opportunity to provide information on a new Office of Management and Budget (OMB) information collection, Control Number 0917-XXXX, titled, ``Tribal Investment in Commercial Electronic Health Records.'' This proposed information collection project has been granted an emergent review by OMB. The purpose of this notice is to provide the public a notice of the information sent directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).

HRSA announces the award of a supplement in the amount of $175,000 for a HRSA-funded cooperative agreement awarded to the University of Southern Maine Rural Health Research Center. The supplement will fund a comprehensive region wide assessment of health issues to improve health care in rural areas of the Northern Border Region (NBR) of the U.S.Grant Number U1CRH03716.

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB #0970-0401). There are no changes to the proposed types of information collection or uses of data, but ACF is requesting an increase to the estimated number of respondents.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Rick Shepard for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Shepard was convicted of one felony count under Federal law for conspiracy to import and introduce misbranded drugs into interstate commerce. The factual basis supporting Mr. Shepard's conviction is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Shepard was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 14, 2021 (30 days after receipt of the notice), Mr. Shepard had not responded. His failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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 proposed renewal for the information collection requirements related to State Grants for Assistive Technology Program State Plan for Assistive Technology.

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 revision 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 FDA's Federal-State Food Regulatory Program Standards.

The Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for the IQOS 3 System Holder and Charger submitted by Philip Morris Products S.A.

The Food and Drug Administration (FDA or Agency) has determined that OVIDE (malathion) lotion, 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as ``nursing homes'') and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.

Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA or Agency) announces its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS.

The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Seniors and Disasters (NACSD or Advisory Committee). The Advisory Committee will provide advice and recommendations to the Secretary of HHS, in accordance with the Federal Advisory Committee Act (FACA), to support and enhance all-hazards public health and medical preparedness, response activities, and recovery aimed at meeting the unique needs of seniors (older adults). The ASPR shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACSD. Up to seven new voting members with expertise in senior medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACSD website at www.phe.gov/nacsd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.

This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.'' This guidance describes FDA's current recommendations regarding phase 2 or phase 3 trials for drugs or biological products under development for the treatment or prevention of COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. This final guidance revises and replaces the final guidance of the same name issued on May 11, 2020. Revisions were made to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of COVID-19 vaccines. The revision to this guidance was posted to the FDA website on February 22, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance provides key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. The guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays. This guidance finalizes the draft guidance issued on November 13, 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Q3D(R2) Guideline for Elemental Impurities.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided. The draft guidance is intended to recommend acceptable amounts for the listed elemental impurities in pharmaceuticals for the safety of the patient and provide recommendations for conducting a risk assessment for pharmaceutical products.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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.

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance, which consists of a Guidance and Annexes, provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/biological products. This guidance finalizes the draft guidance of the same title issued on May 31, 2018.

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 Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of additional technical instructions and documents released under its Framework for Conditional Sailing Order (CSO). These documents apply to cruise ship operators with cruise ships operating in U.S. waters and cruise ship operators who are operating cruise ships outside of U.S. waters, but intend for their cruise ships to return to operating in U.S. waters while CDC's Conditional Sailing Order remains in effect.