Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place via webinar. This webinar will be open to the public. Registration is required for those who wish to provide public testimony.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the National Resource Center on Domestic Violence (NRCDV) in Harrisburg, PA
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $236,000 as a single-source program expansion supplement to the National Resource Center on Domestic Violence in Harrisburg, PA. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs.
Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket
The Food and Drug Administration (FDA or the Agency) is announcing the opening of a public docket and requesting comments on proposed criteria for ``first generic'' abbreviated new drug application (ANDA) submissions. The purpose is to facilitate FDA's establishment of review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA). Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of ``first generic'' submissions.
Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled ``Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.'' CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness.
Prospective Grant of Exclusive License: Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Amprion, Inc. located in Houston Texas, USA, to practice the inventions embodied in the following Patents and Patent Applications, each entitled ``Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein'': 1. US provisional Application 60/961,364 filed July 20, 2007 [HHS Ref. No. E-109-2007/0-US-01] 2. PCT/US2008/070656, filed July 21, 2008; [HHS Ref. No E-109-2007/ 1-PCT-01] 3. EPC application No 08796382.3 filed July 21, 2008 [HHS Ref. No E-109-2007/1-EP-03] 4. US Application No. 12/177,012, filed July 21, 2008 and issued as US patent 8,216,788 on July 10, 2012 [HHS Ref. No E-109-2007/1-US-02]; 5. US Application No. 13/489,321, filed June 5, 2012 [E-109-2007/1- US-04]; 6. US Application No. 14/263,703, filed April 28, 2014 [E-109-2007/ 1-US-011] The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to in vitro diagnostics of prion- associated diseases requiring FDA premarket approval, or the equivalent thereof outside of the United States, and USDA licensed veterinary diagnostics, or the equivalents thereof outside of the United States.
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 extending the use of the approved information collection assigned OMB control number 0990-0422, which expires on August 31, 2015. 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.
Questions and Answers Regarding Food Facility Registration (Sixth Edition); Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Sixth Edition).'' The guidance includes one additional question and answer regarding FDA's policy regarding food facility registration for farms that also pack or hold raw agricultural commodities grown on a farm under different ownership in light of other ongoing FDA Food Safety Modernization Act (FSMA) rulemakings.
Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Vaginal Microbicides: Development for the Prevention of HIV Infection.'' The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides. This guidance finalizes the draft guidance issued on November 23, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products (MRTPs).