Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Proposed Collection; Comment Request; Application Forms for Research Development and Training Grants
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 collections via application forms, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed collections 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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 request more information on the proposed programs submit requests to: Jack Stein, Ph.D., Director, Office of Science Policy and Communications, National Institute on Drug Abuse, 6001 Executive Blvd., Room 5185, Rockville, MD 20852, or call non-toll free number 301-443-6071 or email your request, including your address to: firstname.lastname@example.org. Comments Due Date: Comments regarding these programs are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Application Forms for Research Development and Training Grants, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: These programs offer grants and traineeships necessary for growing the biomedical researcher workforce, and the diversity in this workforce. The application forms will collect information of applicants for selecting those that would benefit most effectively from the programs. NIDA is requesting generic approval from OMB for application forms to be used by these programs that will recruit pre-college through post-doctoral underrepresented individuals and individuals of special populations into the research programs of the Institute for research training and research development, for forging mentor/mentee relationships and networking between newly funded underrepresented researchers and experienced investigators funded by NIDA; and for a fellowship program to train new researchers, and support experienced researchers of other nations, in research to advance the science of HIV and drug use while fostering multinational research in this disease area. The application forms will be web-based. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 426.
Submission for OMB Review; 30-day Comment Request; a Generic Submission for Theory Development and Validation (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 14, 2014, Vol. 79, page 40763 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Pediatric Liquid Drug Products Containing Acetaminophen.'' The draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over- the-counter (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.
The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.'' FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).
Critical Path Innovation Meetings; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Critical Path Innovation Meetings.'' This draft guidance describes a Critical Path Innovation Meeting (CPIM), a means by which FDA's Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.
Prescription Drug User Fee Act Patient-Focused Drug Development; Request for Comments
The Food and Drug Administration (FDA) is announcing an opportunity for public comment related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining the patient perspective on disease severity and currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for consideration in patient-focused drug development meetings during fiscal years (FYs) 2016-2017. The public is invited to comment on this preliminary list through a public docket.
Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.