National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Request for Public Comment: 30-Day Notice for Extension of Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys'' (OMB Control Number 0917-0036), which expires July 30, 2018. This proposed information collection project was recently published in the Federal Register on September 27, 2017, and allowed 60 days for public comment. The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_001).
Request for Public Comment: 60 Day Proposed Information Collection: Indian Health Service Information Security Ticketing and Incident Reporting
In compliance with the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-XXXX, titled, Information Security Ticketing and Incident Reporting. The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_001).
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; ADVANTAME
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADVANTAME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.
Proposed Data Collection Submitted for Public Comment and Recommendations-National Hospital Ambulatory Medical Care Survey (NHAMCS)
The Centers for Disease Control and Prevention (CDC) requested publication of a document in the Federal Register. Document 2017-25496, Proposed Data Collection Submitted for Public Comment and RecommendationsNational Hospital Ambulatory Medical Care Survey (NHAMCS), has been scheduled to publish on November 27, 2017. The document provided the incorrect docket number (CDC-2018-0101).
The Food and Drug Administration's Approach To Evaluating Nicotine Replacement Therapies; Public Hearing; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should be used and labeled.