Department of Health and Human Services September 2016 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 323
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22392
Type: Notice
Date: 2016-09-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22391
Type: Notice
Date: 2016-09-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22389
Type: Notice
Date: 2016-09-19
Agency: Department of Health and Human Services, National Institutes of Health
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2016-22376
Type: Notice
Date: 2016-09-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2016-22375
Type: Notice
Date: 2016-09-19
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers.'' The draft questions and answers (Q&As) guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft Q&As guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology- derived products, intended to treat patients with cancer. The Q&As are intended to provide additional clarity for topics discussed in the ICH guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' (S9 guidance).
Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability
Document Number: 2016-22353
Type: Notice
Date: 2016-09-16
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 document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008.
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
Document Number: 2016-22352
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public workshop regarding ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs).'' This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.
Clinical Investigator Training Course
Document Number: 2016-22348
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is announcing a 3-day training course for clinical investigators on the scientific, ethical, and regulatory aspects of clinical trials for medical products. This training course is intended to provide clinical investigators, such as clinicians, nurses, pharmacists, and other health care providers involved in conducting clinical trials, with expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. Senior FDA staff, along with other experts, will present on issues critical for successful conduct of clinical research.
Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Guidance for Industry; Availability
Document Number: 2016-22347
Type: Notice
Date: 2016-09-16
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 guidance for industry entitled ``Qualification of BiomarkerTotal Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs)without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON
Document Number: 2016-22345
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for LUMASON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO
Document Number: 2016-22344
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ENTYVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM
Document Number: 2016-22343
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-22342
Type: Notice
Date: 2016-09-16
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 any of the following subjects: 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; Unique Device Identification System
Document Number: 2016-22340
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 associated with the Unique Device Identification System.
Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised Guidance for Industry; Availability
Document Number: 2016-22339
Type: Notice
Date: 2016-09-16
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 revised guidance for industry (GFI) #171 entitled ``Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,\1\ particularly the section on Criteria for Waiver of In Vivo Bioequivalence Study. This guidance is applicable to generic investigational new animal drug (JINAD) files and abbreviated new animal drug applications (ANADAs). Although the recommendations in this guidance reference generic drug applications, the general principles described may also be applicable to new animal drug applications (NADAs), investigational new animal drug (INAD) files, and supplemental NADAs.
Menu Labeling Public Workshop; Public Meeting
Document Number: 2016-22337
Type: Notice
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a third public meeting to discuss menu labeling requirements. We announced the first two public meetings in a separate Federal Register notice earlier this year. The purpose of the public meetings is to help the regulated industry comply with the requirements of the menu labeling final rule.
Submission for OMB Review; Comment Request
Document Number: 2016-22316
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, Administration for Children and Families
McCormick & Company, Inc.; Filing of Color Additive Petition
Document Number: 2016-22289
Type: Proposed Rule
Date: 2016-09-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs at levels consistent with good manufacturing practice.
CARA Act's Required Training of Nurse Practitioners and Physician Assistants
Document Number: 2016-22279
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public meeting on October 1, 2016, to discuss the training requirements for nurse practitioners (NPs) and physician assistants (PAs) that have been stipulated in the Comprehensive Addiction and Recovery Act (CARA). The session will be held in Newark, NJ.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-22275
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2016-22274
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, Notice of Meeting
Document Number: 2016-22273
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2016-22272
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2016-22271
Type: Notice
Date: 2016-09-16
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
Document Number: 2016-21404
Type: Rule
Date: 2016-09-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid- participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.
Notice of Opportunity for Public Comment on the Office of Dietary Supplements Draft 2016-2021 Strategic Plan
Document Number: 2016-22233
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has initiated a strategic planning process that will culminate in the ODS Strategic Plan for 2016-2021. To assist with this process, the ODS requests input from research communities academic, government, and industryand from other interested parties. The overall purpose of the strategic planning effort is to identify both new opportunities and emerging needs for incorporation in the programmatic efforts of the Office. A draft is available on the ODS Web site at ods.od.nih.gov/StrategicPlan.
Advisory Commission on Childhood Vaccines
Document Number: 2016-22193
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that a meeting is scheduled for Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/advisorycommittees/childhoodvaccines/ index.html.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-22165
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-22164
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-22163
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, National Institutes of Health
A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
Document Number: 2016-22132
Type: Notice
Date: 2016-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting concerning a universal closed system drug- transfer device (CSTD) testing protocol entitled, A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, http://www.cdc.gov/ niosh/topics/hazdrug/default.html/. This is an opportunity for public comment on the protocol, the proposed list of surrogates, and to respond to NIOSH questions regarding the protocol. To view the protocol and related materials, visit www.regulations.gov and enter CDC-2016-0090 in the search field and click ``Search.'' Table of Contents
CARA Act's Required Training of Nurse Practitioners and Physician Assistants
Document Number: 2016-22130
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public meeting on October 1, 2016, to discuss the training requirements for nurse practitioners (NPs) and physician assistants (PAs) that have been stipulated in the Comprehensive Addiction and Recovery Act (CARA). The session will be held in Newark, NJ.
Supplement to National Technical Resource Center for the Newborn Hearing Screening and Intervention Program at the Utah State University
Document Number: 2016-21711
Type: Notice
Date: 2016-09-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement in the amount of $300,000 for the National Technical Resource Center (NTRC) for the Newborn Hearing Screening and Intervention program cooperative agreement. Funding in future years is contingent upon satisfactory performance of the recipient, need, and availability of funds. The purpose of the NTRC is to address new research, approaches, and practice advances in the fields of family engagement, early language acquisition, and early literacy. The supplement will fund Utah State University, the cooperative agreement recipient, during the budget periods of the supplement 4/1/2016-3/31/2020, to respond to changes in research, policy, technology, and practice in the newborn hearing screening field in the areas of family engagement, early language acquisition, and early literacy. Funding in FY 2017, FY 2018, and FY 2019, is contingent upon appropriations, satisfactory performance of the recipient, need, and availability of funds.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-22081
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement with change of a previously-approved information collection assigned OMB control number 0990-0324, which expired on 03/31/2011. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)
Document Number: 2016-22059
Type: Notice
Date: 2016-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2016-22058
Type: Notice
Date: 2016-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Vaccines and Related Biological Products Advisory Committee; Cancellation
Document Number: 2016-22051
Type: Notice
Date: 2016-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The meeting of the Vaccines and Related Biological Products Advisory Committee scheduled for November 16, 2016, is cancelled. This meeting was announced in the Federal Register of August 30, 2016 (81 FR 59634).
Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins
Document Number: 2016-22049
Type: Rule
Date: 2016-09-14
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2016-22036
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-22024
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-22023
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2016-22022
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-22021
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-22020
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22019
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-22018
Type: Notice
Date: 2016-09-14
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
Document Number: 2016-21985
Type: Rule
Date: 2016-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.
Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
Document Number: 2016-21984
Type: Notice
Date: 2016-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine. This action is being taken at the sponsor's request because the 3-way Type A medicated article is no longer manufactured.
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Request for Comments
Document Number: 2016-21972
Type: Notice
Date: 2016-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, we) is soliciting comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. This activity is consistent with previous efforts by FDA to protect public health by promoting the judicious use of these drugs in food-producing animals.
Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Document Number: 2016-21969
Type: Notice
Date: 2016-09-13
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 document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). Specifically, the guidance provides recommendations regarding the use of an FDA-licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. This guidance supplements the donor screening recommendations for WNV (which will remain in place) in sections IV.E. (recommendations 15 and 16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus (WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).