Proposed Data Collections Submitted for Public Comment and Recommendations; List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products; Withdrawn
The Centers for Disease Control and Prevention requests withdrawal from publication the 60-Day Federal Register Notice (FRN) 14 0210 concerning the List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products (FR Doc. 2013-26469), which was submitted on October 30, 2013 for public inspection in the Federal Register. The purpose behind this notice withdrawal request is that an original 60-day FRN was previously published on October 31, 2013 (Document Number2013-25799). A duplicate 60-day FRN was inadvertently published on November 5, 2013. Please disregard the duplicate FRN.
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of September 13, 2013, for the final rule that appeared in the Federal Register of August 13, 2013. The final rule amended the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.
Draft Current Intelligence Bulletin “Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ``Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace.'' To view the notice, document and related materials, visit http://www.regulations.gov and enter CDC-2013-0023 in the search field and click ``Search.'' Additional information is also located at the following Web site: http://www.cdc.gov/niosh/topics/ cancer/policy.html. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: Comments must be received by February 13, 2014. Public Meeting Time and Date: December 16, 2013, 9 a.m.-4 p.m., Eastern Time. Please note that public comments may end before the time indicated, following the last call for comments. Members of the public who wish to provide public comments should plan to attend the meeting at the start time listed. Place: Surface Transportation Board Hearing Room, Patriots Plaza One, 395 E Street SW., 1st Floor, Room 120, Washington, DC 20201. Status: The meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people. In addition, there will be an audio conference for those who cannot attend in person. There is no registration fee to attend this public meeting. However, those wishing to attend are encouraged to register by December 3, 2013 with the NIOSH Docket Office at 513/533- 8611 or email firstname.lastname@example.org. Security Considerations: Due to mandatory security clearance procedures at the Patriots Plaza Building, in-person attendees must present valid government-issued picture identification to security personnel upon entering the building and go through an airport-type security check. Non-U.S. citizens: Because of CDC Security Regulations, any non- U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than November 22, 2013 to allow time for mandatory CDC facility security clearance procedures to be completed. 1. Name: 2. Gender: 3. Date of Birth: 4. Place of birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. U.S. Naturalization Number (if a naturalized citizen): 11. U.S. Naturalization Date (if a naturalized citizen): 12. Visitor's Organization: 13. Organization Address: 14. Organization Telephone Number: 15. Visitor's Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. Non-U.S. citizens are encouraged to participate in the audio conferencing due to the extra clearance involved with in-person attendance. Attendee and Speaker Registration: Attendees are encouraged to sign up by December 3, 2013 with the NIOSH Docket Office. Individuals wishing to speak during the meeting may sign up when registering with the NIOSH Docket Office no later than December 3, at 513/533-8611 or by email at email@example.com. Those who have not signed up to present in advance may be allowed to present at the meeting if time allows. Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting must also be submitted to the docket in writing in order to be considered by the Agency. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace.'' Special emphasis will be placed on discussion of the following:
Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.
Draft Guidance for Industry on Acrylamide in Foods; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches.
Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public Hearing
The Food and Drug Administration (FDA) is rescheduling a December 4, 2013, public hearing to obtain information on the formulation, manufacturing, and labeling of currently marketed over- the-counter (OTC) emergency use eyewash products, announced in the Federal Register of Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public hearing to March 7, 2014, and updating the related procedural dates that appeared in the September 18, 2013, notice.
International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability
The Food and Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the diverse international regulatory requirements of medical devices quality management systems and other specific regulatory requirements of the regulatory authorities participating in the pilot program. FDA will be participating in the MDSAP and will accept the resulting audit reports as a substitute for routine Agency inspections.
Fiscal Year (FY) 2014 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $459,505 (total costs) for up to five years to CADCA for the National Substance Abuse Leadership Forum Cooperative Agreement. Under this initiative, CADCA will provide training and technical assistance to a large number of community leaders across the country who are committed to behavioral health (i.e., prevention, recovery, resilience, and wellness); and address current issues related to the prevention and treatment of substance abuse, and/or mental disorders across the nation. Conference and training activities supported through this cooperative agreement include SAMHSA's Prevention Day, the Community Anti-Drug Coalitions of America's (CADCA) National Leadership Forum, and CADCA's Mid-Year Training Institute. These conferences serve as a portal for knowledge dissemination and state-of-the-art information transfer; and assist community leaders in developing effective local programs, practices, and policies that support national substance abuse prevention goals, outcomes and efforts, such as National Alcohol and Drug Addiction Recovery Month, National Substance Abuse Prevention Month, and underage drinking prevention. The CADCA Conference initiative directly supports SAMHSA's mission to reduce the impact of substance abuse and mental illness on America's communities. This is not a formal request for applications. Assistance will be provided only to CADCA based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-14-001. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 516 of the Public Health Services Act, as amended. Funds for a portion of this initiative are also authorized under Sections 509, 516 and 520A of the Public Health Service Act, as amended. Justification: Eligibility for this award is limited to CADCA. The purpose of this cooperative agreement is to provide training and technical assistance for thousands of members of community coalitions dedicated to preventing substance abuse through a national leadership conference. CADCA is the only national organization that has special expertise and unique broad, national-level experience in working with community anti-drug coalitions. For more than 18 years, coalitions and coalition leadership have turned to CADCA to obtain the assistance they need to implement, operate, and sustain effective local community anti- drug strategies. The CADCA will take advantage of the resources of multiple agencies located throughout the federal, state and local governments, philanthropies, and universities to bring the best available knowledge, information, and technology to local community anti-drug coalitions working to prevent and reduce drug use among the youth of America. CADCA is the only identified organization with the required experience and national reach to over 5,000 identified anti- drug coalitions across the country. CADCA has long been recognized in communities as well as states throughout the nation as the national voice for the advocacy and technical support of anti-drug coalitions. As such, it is uniquely qualified and positioned to carry out the requirements of this announcement. Contact: Cathy Friedman, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1097, Rockville, MD 20857; telephone: (240) 276-2316; email: firstname.lastname@example.org.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Development Tools.'' This document provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
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 FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of our existing regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.
Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' We are reopening the comment period in response to requests for an extension to allow interested persons additional time to submit comments.
Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds; Request for Comments
The Food and Drug Administration (FDA) is considering revising the guidance entitled ``Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is seeking comments on this guidance before revisions are made.
Bruce I. Diamond; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying Dr. Bruce I. Diamond's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Diamond for 10 years from providing services in any capacity to a person who has an approved or pending drug product application. FDA bases this order on findings that Dr. Diamond was convicted of felonies under State law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act, was convicted of felonies involving fraud, and was a material participant in acts forming the basis of a conviction that subjects another person to debarment. In determining the appropriateness and length of Dr. Diamond's debarment period, FDA has evaluated the relevant considerations listed in the FD&C Act. Dr. Diamond has failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-002, Addressing Methodological Challenges in Research for Patients With Multiple Chronic Conditions (R21)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-001, Rapid Secondary Analysis to Optimize Care for Patients with Multiple Chronic Conditions (R01)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Announcement of Solicitation of Written Comments on Modifications of Healthy People 2020 Objectives
The U.S. Department of Health and Human Services (HHS) solicits written comments regarding new objectives proposed to be added to Healthy People 2020 since the fall 2012 public comment period, as well as written comments proposing new objectives to be included within existing Healthy People 2020 Topic Areas. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People 2020 will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.HealthyPeople.gov. This set will reflect further review and deliberation by the Topic Area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.
Request for Information on Alternative Skin Sensitization Test Methods and Testing Strategies and for Comment on ICCVAM's Proposed Activities
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is developing a U.S. plan for the evaluation of alternative skin sensitization test methods and testing strategies. The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests information that ICCVAM might use to develop this plan and comments on proposed ICCVAM activities.
Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008; Technical Amendment to External Review for Multi-State Plan Program
This document contains final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, which requires parity between mental health or substance use disorder benefits and medical/surgical benefits with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage. This document also contains a technical amendment relating to external review with respect to the multi-state plan program administered by the Office of Personnel Management.
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the ``Highlights of Prescribing Information'' for drug products with labeling in the ``Physician Labeling Rule'' (PLR) format.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All Vaccines Against Seasonal Influenza
Through this notice, the Secretary of the U.S. Department of Health and Human Services (the Secretary) announces that all FDA- approved vaccines against seasonal influenza are covered under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. Prior to this publication, trivalent influenza vaccines were included under Category XIV on the Vaccine Injury Table (Table) and will continue to be listed in that category. This notice serves to include all vaccines against seasonal influenza (not already covered under Category XIV) as covered vaccines under Category XVII of the Table (new vaccines covered under the VICP). This notice ensures that petitioners may file petitions relating to all vaccines against seasonal influenza (not already covered under the VICP) with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Hao Wang, M.D., Ph.D., Western UniversityCanada (formerly University of Western Ontario): Based on the report of an investigation conducted by Western UniversityCanada (WU) and ORI's subsequent oversight analysis, ORI found that Dr. Hao Wang, former Associate Professor of Surgery and Pathology, Schulich School of Medicine and Dentistry, WU, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), subaward 0016244 from Prime Award U01 AI074676 to the University of Pittsburgh. ORI found that Respondent engaged in research misconduct by falsifying data that were included in: An abstract and poster presentation for the 2011 American Transplant CongressAbstract [1537.5]: Wang, H., Baroja, M., Lan, Z., Arp, J., Lin, W., Relmann, K., Garcia, B., Jevnikar, A., & Rothstein, D. ``Combination of Novel Anti-CD45RB and Anti-CD40 Chimeric Antibodies Proglons Renal Allograft Survival in Cynomolgus Monkeys.'' Specifically, ORI found that the Respondent falsified the status of two animals as successfully treated renal allograft recipients in a 2011 American Transplant Congress abstract and meeting presentation and in false representations to the project principal investigators and colleagues. Respondent falsely claimed long term survival, normal serum creatinine concentrations, and lack of adverse effects in two Cynomolgus monkeys treated with chimeric antibodies following bilateral nephrectomies and receipt of renal allografts, when in fact the transplant surgery had failed and the animals' survival was due to a native kidney that was left in place in each animal. Respondent also falsified or failed to correct known falsifications (identifying the two monkeys as transplant recipients) in numerous clinical records, including anesthesia records, progress, notes, treatment records, and clinical laboratory reports. It is expressly agreed that while Respondent asserts that there are extenuating factors for his actions, Respondent agrees to enter into the Agreement because contesting the findings would cause him undue financial hardship and stress, and Respondent wishes to seek finality. Respondent also claims that based on the data obtained from the same experimental group, the removal of these two monkeys from the data would not alter the scientific conclusion. Dr. Wang has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on October 22, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed-upon supervision plan; (2) that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submission is his own or properly cites the source of copied language and ideas; and (3) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.