Department of Health and Human Services June 29, 2018 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry #252 entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule we issued in the Federal Register of May 11, 2016, entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
The Food and Drug Administration (FDA or the 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 information collection supporting the Agency's Biosimilars User Fee Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
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 the recommended labeling of certain beers subject to our labeling jurisdiction.
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in nonclinical studies and product labeling, and reduce the conduct of nonclinical studies that are not informative for product use.
The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
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.
Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2018. The notice announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, effective April 13, 2018. In particular, the notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, and 2 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 076045 is still in effect.
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain changes in policies and procedures surrounding its application.
Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach To Address the Opioid Crisis
This Request for Information (RFI) is intended to gather broad public input on the conduct of a multi-site national research effort to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (e.g., Hepatitis C and HIV), increase the number of individuals receiving medication-assisted treatment (MAT), increase the proportion retained in treatment beyond 6 months, and increase the number of individuals receiving needed recovery support services.
Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER staff experiential learning site visit program specific to FDA's Quality Metrics Program. FDA is proposing this program, in part, in response to input from a variety of stakeholders over the past couple of years. The purpose of this 2018 Quality Metrics Site Visit Program is to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program. This notice invites pharmaceutical companies interested in participating in this program to submit a Quality Metrics Site Visit proposal.
Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program
The Food and Drug Administration (FDA, Agency, or we) Center for Drug Evaluation and Research (CDER) is announcing two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. These efforts include Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply (e.g., active pharmaceutical ingredients (API) establishments, contract manufacturing organizations, over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments). Participation in either of these efforts is voluntary and the programs are intended to foster the joint efforts of FDA and stakeholders to further develop an FDA Quality Metrics Program. The FDA Quality Metrics Program aims to evaluate a new approach for regulatory oversight of pharmaceutical products through the collection of certain quality information developed and maintained in the course of manufacturing drugs under current good manufacturing practices. FDA intends to use quality metrics data to further develop the Agency's risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments) to improve the efficiency and effectiveness of establishment inspections, improve FDA's evaluation of drug manufacturing and control operations, and identify situations in which there may be a risk for drug supply disruption.
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.
Healthcare Infection Control Practices Advisory Committee (HICPAC); Notice of Charter Amendment
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to increase the number and meetings from approximately three times per year to up to eight times per year. Also, this amendment gives notice to change the name of the DNV Healthcare to DNV-GL; to add the American Society of Nephrology (ASN), the American Association of Kidney Patients (AAKP), the Pediatric Infectious Disease Society (PIDS), and the National Association of Directors of Nursing Administration (NADONA) as non-voting liaison organizations to the committee, and to include expertise in environmental microbiology; and increase the number of meetings up to eight times a year. The amended filing date is May 4, 2018.
National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2020.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 21, 2020.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Faculty Loan Repayment Program, OMB No. 0915-0150-Extension
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
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