Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 3,929
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-27592
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-27591
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Amended; Notice of Meeting
Document Number: 2013-27590
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27589
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Document Number: 2013-27556
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
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 August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for public comment. There were no public comments 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.
Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)
Document Number: 2013-27554
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
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 August 30, 2013, Vol. 78, p. 53763 and allowed 60-days for public comment. There have been no public comments. 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.
Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators
Document Number: 2013-27445
Type: Proposed Rule
Date: 2013-11-19
Agency: Department of Health and Human Services
On September 17, 2013, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) held a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting was to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest were included in the meeting notice published in the Federal Register on September 4, 2013. Written comments were to be received by October 18, 2013. HHS/CDC received a request from a stakeholder for additional time to comment on this notice. In consideration of this request HHS/CDC is reopening the public comment period through December 31, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Extension of Comment Period
Document Number: 2013-27537
Type: Notice
Date: 2013-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the information collection entitled ``Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers'' that appeared in the Federal Register of September 18, 2013 (78 FR 57391). In the notice requesting comment on the proposed information collection, we requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments on the proposed information collection.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2013-27536
Type: Notice
Date: 2013-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
Document Number: 2013-27503
Type: Notice
Date: 2013-11-18
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 the information collection in the guidance for industry on special protocol assessment.
Performance Review Board Members
Document Number: 2013-27501
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2013.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27485
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period
Document Number: 2013-27479
Type: Proposed Rule
Date: 2013-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the ``Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of August 19, 2013. We are taking this action to allow interested persons an opportunity to provide comment on the scope of issues the Agency should include in the Environmental Impact Statement (EIS), including their significance, as part of the scoping process for the EIS.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-27455
Type: Notice
Date: 2013-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27447
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Performance Review Board Members
Document Number: 2013-27423
Type: Notice
Date: 2013-11-18
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-27176
Type: Notice
Date: 2013-11-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 14th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-27410
Type: Notice
Date: 2013-11-15
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 reinstating the use of the approved information collection assigned OMB control number 0990-0317, which expired on October 31, 2013. 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.
Proposed Data Collections Submitted for Public Comment and Recommendations; List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products; Withdrawn
Document Number: 2013-27403
Type: Notice
Date: 2013-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27402
Type: Notice
Date: 2013-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
Document Number: 2013-27381
Type: Rule
Date: 2013-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
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”
Document Number: 2013-27375
Type: Notice
Date: 2013-11-15
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 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 niocindocket@cdc.gov. 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 nioshdocket@cdc.gov. 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:
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27372
Type: Notice
Date: 2013-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
Document Number: 2013-27365
Type: Rule
Date: 2013-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27362
Type: Notice
Date: 2013-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27359
Type: Notice
Date: 2013-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27358
Type: Notice
Date: 2013-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27357
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2013-27355
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2013-27354
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-27353
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-27352
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-27351
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-27350
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2013-27349
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-27348
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Fiscal Year (FY) 2014 Funding Opportunity
Document Number: 2013-27334
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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: cathy.friedman@samhsa.hhs.gov.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-27305
Type: Notice
Date: 2013-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including 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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27275
Type: Notice
Date: 2013-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27274
Type: Notice
Date: 2013-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-27244
Type: Notice
Date: 2013-11-14
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 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
Document Number: 2013-27233
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27226
Type: Notice
Date: 2013-11-14
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 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
Document Number: 2013-27222
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-27221
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period
Document Number: 2013-27213
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27194
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27186
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-27174
Type: Notice
Date: 2013-11-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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
Document Number: 2013-27173
Type: Notice
Date: 2013-11-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.