2015 – Federal Register Recent Federal Regulation Documents
Results 3,551 - 3,600 of 30,167
Reserve Requirements of Depository Institutions
The Board is amending Regulation D, Reserve Requirements of Depository Institutions, to reflect the annual indexing of the reserve requirement exemption amount and the low reserve tranche for 2016. The Regulation D amendments set the amount of total reservable liabilities of each depository institution that is subject to a zero percent reserve requirement in 2016 at $15.2 million (from $14.5 million in 2015). This amount is known as the reserve requirement exemption amount. The Regulation D amendments also set the amount of net transaction accounts at each depository institution (over the reserve requirement exemption amount) that is subject to a three percent reserve requirement in 2016 at $110.2 million (from $103.6 million in 2015). This amount is known as the low reserve tranche. The adjustments to both of these amounts are derived using statutory formulas specified in the Federal Reserve Act. The Board is also announcing changes in two other amounts, the nonexempt deposit cutoff level and the reduced reporting limit, that are used to determine the frequency at which depository institutions must submit deposit reports.
NASA Advisory Council; Meeting
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the NASA Advisory Council.
60-Day Notice of Proposed Information Collection: Previous Participation Certification; OMB No.: 2502-0118
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
30-Day Notice of Proposed Information Collection: Legal Instructions Concerning Applications for Full Insurance Benefits-Assignment of Multifamily Mortgages to the Secretary
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
60 Day Notice of Proposed Information Collection: Comment Request; Notice of Application for Designation as a Single Family Foreclosure Commissioner
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Boundary Revision of Acadia National Park
Notice is hereby given that, pursuant to appropriate authorities, the boundary of Acadia National Park in the State of Maine is modified to include approximately 1,441 acres of adjacent land. Following this boundary revision, the property will be donated to the United States and managed as a part of the park.
Proposed Collection; Comment Request for Form 4255
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4255, Recapture of Investment Credit.
Agency Information Collection Activities: Collection of Qualitative Feedback Through Focus Groups; Extension, Without Change, of a Currently Approved Collection
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Entergy Nuclear Operations, Inc.; Vermont Yankee Nuclear Power Station
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Entergy Nuclear Operations, Inc. (Entergy, the licensee), to withdraw its application dated September 4, 2014, for a proposed amendment to Renewed Facility Operating License No. DPR-28, for the Vermont Yankee Nuclear Power Station (VY). The proposed amendment would have replaced VY's decommissioning trust fund (DTF) license conditions with the NRC's regulations governing decommissioning trust funds.
Surety Companies Acceptable on Federal Bonds: Change In Business Address Colonial Surety Company
This is Supplement No. 4 to the Treasury Department Circular 570, 2015 Revision, published July 1, 2015, at 80 FR 37735.
Proposed Data Collection Submitted for Public Comment and Recommendations
The notice ``Proposed Data Collection Submitted for Public Comment and Recommendations'' on Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement (80 FR 68543, November 5, 2015) is cancelled. This notice invited comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement,'' where CDC would use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes. This proposed data collection also received publication for public comment on November 9, 2015 under Docket ID 60Day-16-16BZ; Docket No. CDC-2015-0095.
Proposed Collection; Comment Request for Regulation Project
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning modifications of commercial mortgage loans held by a real estate mortgage investment conduit.
Endangered and Threatened Species Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered or threatened species. The Endangered Species Act of 1973, as amended (Act), prohibits activities with endangered and threatened species unless a Federal permit allows such activities. Both the Act and the National Environmental Policy Act require that we invite public comment before issuing these permits.
Administration of Multiemployer Plan Participant Vote on an Approved Suspension of Benefits Under MPRA; Hearing
This document provides notice of public hearing on proposed regulations relating to the administration of a multiemployer plan participant vote on an approved suspension of benefits under the Multiemployer Pension Reform Act of 2014 (MPRA) that were issued in the Proposed Rules section of the Federal Register on September 2, 2015.
Endangered and Threatened Species Permit Applications; Turner Endangered Species Fund, Bozeman, Montana; Correction
On April 2, 2015, we, the U.S. Fish and Wildlife Service (Service), published a notice in the Federal Register announcing receipt of an application from the Turner Endangered Species Fund for an endangered and threatened species permit pursuant to the Endangered Species Act of 1973, as amended (Act). The notice contained an incorrect permit number. The correct permit number is TE-43754A. With this notice, we correct that error. If you sent a comment previously, you need not re-send the comment.
Filing of Plats of Survey: Oregon/Washington
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
Privacy Act of 1974, as Amended; Computer Matching Program (SSA/Office of Child Support Enforcement (OCSE))-Match Number 1098
In accordance with the provisions of the Privacy Act, as amended, this notice announces a new computer matching program that we are currently will conduct with OCSE.
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseLabeling for Products That Contain Acetaminophen.'' The guidance is intended to inform manufacturers of certain nonprescription (also referred to as over-the- counter or OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances for which FDA does not intend to object to the inclusion of a liver warning that differs from that required under FDA regulations, provided the warning appears as described in the guidance.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that STRENSIQ (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. FDA is publishing in this proposed rule the recommendations of the Panel regarding the classification of the devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care. CDC is requesting a 3-year approval for revision to the previously approved project to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for extension to the previously approved project used to collect data from participants to monitor and evaluate performance and practices among national laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results.
Collection of Connected Entity Data from Regional Transmission Organizations and Independent System Operators
In this order, the Federal Energy Regulatory Commission (Commission) grants a motion for a technical conference and request to postpone comment deadline that was filed in response to the Notice of Proposed Rulemaking for the Collection of Connected Entity Data from Regional Transmission Organizations and Independent System Operators (NOPR) that Commission issued on September 17, 2015.\1\ The Commission directs staff to convene a technical conference on December 8, 2015 and postpones the due date for comments on the NOPR until January 22, 2016, 45 days after the technical conference.
Additional Designations, Foreign Narcotics Kingpin Designation Act
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of two individuals and two entities whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act) (21 U.S.C. 1901-1908, 8 U.S.C. 1182).
Endangered and Threatened Species; Determination on the Designation of Critical Habitat for Three Scalloped Hammerhead Shark Distinct Population Segments
We, NMFS, find that there are no marine areas within the jurisdiction of the United States that meet the definition of critical habitat for the Central and Southwest (Central & SW) Atlantic Distinction Population Segment (DPS), Indo-West Pacific DPS, or Eastern Pacific DPS of scalloped hammerhead shark. Based on a comprehensive review of the best available scientific and commercial data for use in the identification of critical habitat, we find that there are no identifiable physical or biological features that are essential to the conservation of these scalloped hammerhead DPSs and found within areas under U.S. jurisdiction, or any areas outside of the geographical area occupied by the listed DPSs under U.S. jurisdiction that are considered essential to their conservation. As such, we find that there are no specific areas under the jurisdiction of the United States that meet the definition of critical habitat.
Notice of Public Meeting of the Michigan Advisory Committee for a Meeting To Begin Preparations for a Public Hearing Regarding the Civil Rights Impact of Civil Asset Forfeiture in the State
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Michigan Advisory Committee (Committee) will hold a meeting on Friday, December 18, 2015, at 9:30 a.m. EST for the purpose of discussing preparations for a public hearing on the civil rights impact of civil forfeiture practices in the State. The Committee met on October 30, 2015 and approved a project proposal to take up a study on this topic and potential disparate impact or denial of equal protection under the law on the basis of federally protected classes. Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-455-2296, conference ID: 4597163. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at callen@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// facadatabase.gov/committee/meetings.aspx?cid=255. Click on the ``Meeting Details'' and ``Documents'' links to download. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.
Notice of Public Meeting of the Indiana Advisory Committee to Begin Planning a Series of Public Hearings to Study Civil Rights and the School to Prison Pipeline in Indiana
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday, December 2, 2015, from 12:00-1:00 p.m. EST for the purpose of preparing for a series of public hearings to study Civil Rights and the School to Prison Pipeline in Indiana. Members of the public may listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-438-5453 conference ID: 2772442. Any interested member of the public may call this number and listen to the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Member of the public are also invited to make statements during the scheduled open comment period. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days after the Committee meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at callen@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311. Records and documents discussed during the meeting will be available for public viewing prior to and following the meeting at https://database.faca.gov/committee/meetings.aspx?cid=247 and clicking on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.
Notice of Public Meeting of the Missouri Advisory Committee To Discuss Themes and Findings Resulting From Testimony Received Regarding Civil Rights and Police/Community Interactions in the State
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Missouri Advisory Committee (Committee) will hold a meeting on Wednesday January 20, 2016, for the purpose of discussing oral and written testimony received during two public meetings focused on civil rights and police and community interactions in Missouri. Themes and findings discussed during this meeting will form the basis of a report to be issued to the Commission on this topic. Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-430-8709, conference ID: 8351674. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur regular charges for calls they initiate over wireless lines according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977- 8339 and providing the Service with the conference call number and conference ID number. Members of the public are also entitled to submit written comments; the comments must be received in the regional office within thirty days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at callen@usccr.gov. Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311. Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available at https://database.faca.gov/committee/meetings.aspx?cid=258. Click on ``meeting details'' and ``documents'' to download. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works-Best Practice, Promising Practice, and Local Effort (BPPPLE) Form
In compliance with the Paperwork Reduction Act of 1995, Public Law (Pub. L.) 104-13 [44 United States Code (U.S.C.) Sec. 3507(a)(1)(D)], the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Indian Health Service (IHS) Sharing What Works Best Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' Office of Management and Budget (OMB) Control Number 0917-0034. This previously approved information collection project was last published in the Federal Register (80 FR 61215) on October 9, 2015, and allowed 60 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit this collection, which expires January 31, 2016, to OMB for approval of an extension, and to solicit comments on specific aspects for the proposed information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0008). Proposed Collection: Title: 0917- 0034, Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Type of Information Collection Request: Extension, without revision, of the currently approved information collection, 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. There are no program changes or adjustments in burden hours. Form(s): 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and encourage the creation and utilization of performance driven products/ services by IHS, Tribal, and urban Indian health (I/T/U) programs, the Office of Preventive and Clinical Services' program divisions (i.e., Behavioral Health, Health Promotion/Disease Prevention, Nursing, and Dental) have developed a centralized program database of best practices, promising practices and local efforts (BPPPLE) and resources. The purpose of this collection is to further the development of a database of BPPPLE, resources, and policies which are available to the public on the IHS.gov Web site. This database will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Indian health systems to: (a) Identify evidence based approaches to prevention programs among the I/T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLEs occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U health programs' staff. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Civilian Human Resources Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; 60-Day Comment Request; Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Cancer Therapy Evaluation Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact, Charles Hall, RPh, M.S., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, RM 5W240, MSC 9725, Bethesda, Maryland 20892. Or call non-toll-free number (240) 276-6575, or email your request, include your address to: hallch@mail.nih.gov. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Title: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer, 0925-0613, Expiration Date 03/31/ 2016, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: Revision. The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. The frequency of Response is up to 16 times per year. The affected public is private sector including businesses, other for-profit organizations, and non-profit institutions. The type of respondents are investigators, pharmacists, nurses, pharmacy technicians, and data managers. OMB approval is requested for 3 years. There are no capital costs, operating costs or maintenance costs. The total estimated annualized burden hours are 22,645 hours.
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