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

National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2019-23747
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-23746
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-23745
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-23744
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-23743
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-23733
Type: Notice
Date: 2019-10-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Charter Renewal for the National Advisory Committee on Rural Health and Human Services
Document Number: 2019-23729
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services
In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS or Committee) has been renewed. The effective date of the renewed charter is October 29, 2019.
Meeting of the National Advisory Council on Nurse Education and Practice
Document Number: 2019-23728
Type: Notice
Date: 2019-10-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled public meetings for the 2020 calendar year (CY). Information about NACNEP, agendas, and materials for these meetings can be found on the NACNEP website at https:// www.hrsa.gov/advisory-committees/nursing/index.html.
Proposed Collection; 60-Day Comment Request; Collection of Grants and Contracts Data the Historically Black Colleges and Universities (HBCUS) and Small Businesses May Be Interested in Pursuing, (Office of the Director)
Document Number: 2019-23681
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
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, Office of the Director, Office of Acquisitions and Logistics Management (OALM), Small Business Program Office (SBPO), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2019-23675
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services
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.
Delegation of Authority
Document Number: 2019-23668
Type: Notice
Date: 2019-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports; Draft Guidance for Industry; Availability
Document Number: 2019-23666
Type: Notice
Date: 2019-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format: IND Safety Reports.'' The draft guidance describes the electronic format sponsors will be required to use when they electronically submit to FDA investigational new drug (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for serious and unexpected suspected adverse reactions that are required under the Agency's regulations. FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance, once finalized and effective, will require sponsors submitting the specified IND safety reports electronically to submit the reports to FDA using the FDA Adverse Event Reporting System (FAERS) as structured data elements and will provide sponsors with a reporting format that is consistent with the International Council for Harmonisation (ICH) E2B(R2) format guidelines and reporting requirements to other regulatory agencies. Additional technical specification documents and instructions for submitting IND safety reports, including ``Electronic Submission of IND Safety Reports Technical Conformance Guide'' and an updated technical specifications document entitled ``Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments'' are available on the FAERS Electronic Submission web page (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma tion/ Surveillance/AdverseDrugEffects/ucm115894.htm).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-23648
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2019-23647
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-23646
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-23645
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-23644
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-23643
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-23641
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2019-23640
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2019-23635
Type: Notice
Date: 2019-10-30
Agency: Department of Health and Human Services, Administration for Children and Families
Type V Drug Master Files for Center for Drug Evaluation and Research-Led Combination Products Using Device Constituent Parts With Electronics or Software; Draft Guidance for Industry; Availability
Document Number: 2019-23585
Type: Notice
Date: 2019-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.'' A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. This draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., a CDER-led combination product) and which features a device constituent part with electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products. The draft guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-23584
Type: Notice
Date: 2019-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-23572
Type: Notice
Date: 2019-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Nurse Anesthetist Traineeship (NAT) Program Specific Data Forms, OMB Control No. 0915-0374-Revision
Document Number: 2019-23564
Type: Notice
Date: 2019-10-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 have been provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-23553
Type: Notice
Date: 2019-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System
Document Number: 2019-23471
Type: Rule
Date: 2019-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Recommendations for Hepatitis C Screening Among Adults-2019; Request for Comment
Document Number: 2019-23521
Type: Notice
Date: 2019-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the opening of a public docket to obtain public comment on proposed new recommendations for hepatitis C virus (HCV) infection screening for adults, including pregnant women. The new recommendations are intended for U.S. healthcare providers and will include supporting scientific evidence of the effectiveness and economic value of screening to diagnose current HCV infection among adults and pregnant women in the United States.
Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier
Document Number: 2019-23507
Type: Rule
Date: 2019-10-28
Agency: Department of Health and Human Services, Office of the Secretary
This final rule rescinds the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. This final rule also removes the definitions for the ``Controlling health plan'' (CHP) and ``Subhealth plan'' (SHP).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-23506
Type: Notice
Date: 2019-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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: Proposed Collection; Comment Request
Document Number: 2019-23504
Type: Notice
Date: 2019-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Watson Laboratories, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing
Document Number: 2019-23490
Type: Notice
Date: 2019-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.
Prospective Grant of an Exclusive Patent License: The Development of an Anti-GPC3 Radionuclide Immunoconjugate for the Treatment of GPC3-Expressing Cancers
Document Number: 2019-23481
Type: Notice
Date: 2019-10-28
Agency: Department of Health and Human Services, National Institutes of Health
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 Xsto BioSciences, Inc. (Xsto), located in San Carlos, California.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Document Number: 2019-23464
Type: Rule
Date: 2019-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the self-fitting air-conduction hearing aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
InvaGen Pharmaceuticals, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Trandolapril Tablets; Opportunity for a Hearing
Document Number: 2019-23461
Type: Notice
Date: 2019-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2019-23413
Type: Notice
Date: 2019-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research. The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the National Center for Toxicological Research. At least one portion of the meeting will be closed to the public.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2019-23404
Type: Notice
Date: 2019-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-23403
Type: Notice
Date: 2019-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-23402
Type: Notice
Date: 2019-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-23400
Type: Notice
Date: 2019-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size
Document Number: 2019-23276
Type: Rule
Date: 2019-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is issuing this final rule to revise the type size labeling requirements when front-of- pack (FOP) labeling is used to meet the calorie declaration requirements for articles of food sold from glass-front vending machines. We are taking this action to reduce the regulatory burden on industry, increase flexibility for the labeling of certain articles of food sold from glass-front vending machines, and ensure that consumers continue to have visible FOP calorie information for articles of food at the point of purchase.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-23369
Type: Notice
Date: 2019-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Enhanced STD surveillance Network (SSuN)'', which is the only source for enhanced and sentinel STD surveillance data in the United States that serves to strengthen national and local surveillance capacity, collects information on populations at risk for STDs attending healthcare facilities, and provides more accurate estimates of the burden of disease, incidence of disease, trends and impact of STDs at the population level.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-23368
Type: Notice
Date: 2019-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Post-Acute and Long-Term Care Study. The purpose is to collect data for the residential care community and adult day services center components for the 2020 wave of the National Post-Acute and Long-Term Care Study (formerly the National Study of Long-Term Care Providers).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-23367
Type: Notice
Date: 2019-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-23366
Type: Notice
Date: 2019-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 CDC Ideation Catalyst (I- Catalyst) Program and Customer Engagement Information Collection. CDC will collect qualitative information from potential customers and other stakeholders about their needs and preferred approaches to solving public health problems. Findings will be used to improve customer satisfaction with, and usability of, CDC's products, programs, and services.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-23365
Type: Notice
Date: 2019-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry
Document Number: 2019-23335
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.
Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed; Withdrawal of Guidance
Document Number: 2019-23334
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of Compliance Policy Guide Sec. 400.400 (CPG 400.400) entitled ``Conditions Under Which Homeopathic Drugs May be Marketed,'' which was issued in 1988.
Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2019-23312
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance revises the guidance for industry of the same name issued April 1, 2011. The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials.
Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE
Document Number: 2019-23309
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for LO MINASTRIN FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD, c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan). Allergan notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.