Department of Health and Human Services November 15, 2013 – Federal Register Recent Federal Regulation Documents
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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 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for Public Comment and Recommendations; List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products; Withdrawn
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 https://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: https://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:
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: cathy.friedman@samhsa.hhs.gov.
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.
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