Department of Health and Human Services August 2013 – Federal Register Recent Federal Regulation Documents
Results 251 - 283 of 283
Cooperative Agreement to Support the Food and Agriculture Organization
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2013 to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health. The goal of this collaborative project between FDA and FAO is to contribute to the knowledge base and development of food safety systems globally due to the increasingly diverse and complex food supply. The project is also designed to enhance and broaden FDA's ability to address global food safety and public health issues associated with food as well as provide opportunities to leverage additional resources of other countries. The collaborative project will also support the FDA's implementation of the FDA Food Safety Modernization Act (FSMA), including FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. In addition, the collaborative project will support food safety, nutrition, and public health programs that align with FDA's mission.
Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice of public meeting entitled ``Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV Cure Research,'' published in the Federal Register of May 21, 2013 (78 FR 29755). In that notice, FDA requested public comment regarding patients' perspective on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a previously issued draft guidance on the same subject.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov.
Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year, and publish those rates in the Federal Register 60 days before the start of the upcoming FY. This document establishes FY 2014 rates for an ANDA ($63,860), PAS ($31,930), DMF ($31,460), domestic API facility ($34,515), foreign API facility ($49,515), domestic FDF facility ($220,152), and foreign FDF facility ($235,152). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Prescription Drug User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2014 for application fees for an application requiring clinical data ($2,169,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,084,550), for establishment fees ($554,600), and for product fees ($104,060). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014. For applications and supplements that are submitted on or after October 1, 2013, the new fee schedule must be used. Invoices for establishment and product fees for FY 2014 will be issued in August 2013 using the new fee schedule.
Medical Device User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. The FY 2014 fee rates are provided in this document. These fees apply from October 1, 2013, through September 30, 2014. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2014 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2014 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Biosimilar User Fee Rates for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), which was signed by the President on July 9, 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2014 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013, which was signed by the President on June 13, 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2014.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2014 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013, which was signed by the President on June 13, 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2014.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion
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 concerning establishment notification of a consignee and consignee notification of a recipient's physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection.
Request for Information Regarding Nondiscrimination in Certain Health Programs or Activities
Section 1557 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) (42 U.S.C. 18116) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the Affordable Care Act authorizes the Secretary of the Department of Health and Human Services (Department) to promulgate regulations to implement the nondiscrimination requirements in Section 1557. This notice is a request for information (RFI) to inform the Department's rulemaking for Section 1557. This RFI seeks information on a variety of issues to better understand individuals' experiences with discrimination in health programs or activities and covered entities' experiences in complying with Federal civil rights laws.
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.
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.
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
HHS is soliciting nominations for six non-Federal members of the Advisory Council on Alzheimer's Research, Care, and Services. The six positions are for each of the following categories, as specified in the National Alzheimer's Project Act: Alzheimer's patient advocate, Alzheimer's caregiver, health care provider, representative of state health department, researcher with Alzheimer's-related expertise, and voluntary health association representative. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Solicitation of Written Comments on the Draft Report of the National Adult Immunization Standards of Practice for Consideration by the National Vaccine Advisory Committee
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The ASH has charged the NVAC with examining the current adult immunization environment by updating adult immunization standards of practice with the intention of ultimately impacting Healthy People 2020 goals. A review group was established to address this charge on behalf of the NVAC. Through discussion and careful review, the group has developed draft recommendations for consideration by the NVAC to achieve this charge. It is anticipated that the draft report, as revised with consideration given to public comment and stakeholder input, will be presented in at the NVAC at the September 2013 meeting for deliberation and decision on their final recommendation. The draft report will be made available for public review and written comment.
Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and Draft Recommendations for Enhancing the Work of the HHS National Vaccine Program in Global Immunizations for Consideration by the National Vaccine Advisory Committee
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The ASH charged the NVAC with reviewing the role of HHS in global vaccination, the effects of global vaccination on global populations, the effects of global vaccination on U.S. populations, and recommending how HHS can best continue to contribute, consistent with its newly established Global Health Strategy and Goal 5 of the National Vaccine Plan. The NVAC was also asked to make recommendations on how to best communicate this information to decision makers and the general public to ensure continued sufficient resources for the global vaccination efforts. The NVAC established the Global Immunizations Working Group to assist in addressing these charges. A draft report and draft recommendations have been developed by the working group for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in September 2013 at the quarterly NVAC meeting.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the Annual Report submitted to the Secretary and Congress by the contracted consensus-based entity (CBE) as mandated by section 1890(b)(5) of the Social Security Act, as created by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.
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 revision of a previously-approved information collection assigned OMB control number 0937-0025, which expired on 08/31/2013. 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.
Prospective Grant of Start-up Exclusive License: Kits for the Detection of Human Interferon-Alpha Subtypes and Allotypes
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to practice the inventions embodied in: US provisional application No. 61/116,563, filed November 20, 2008, PCT application No. PCT/US2009/65382, filed November 20, 2009; and corresponding National Phase filings in the US, EP, AU, CA, IL, JP and HK (NIH Ref. E-157-2008/0), titled ``Compositions for Detecting Human Interferon- Alpha Subtypes and Methods of Use'', to IES Diagnostics, LLC having a place of business at 12 Upper Drive, Watchung, NJ 07069. The patent rights in these inventions have been assigned to the United States of America.
Prospective Grant of Start-up Exclusive License: Topical Antibiotic With Immune Stimulating Oligodeoxynucleotide Molecules To Speed Wound Healing; and Use of CpG Oligodeoxynucleotides To Induce Epithelial Cell Growth
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 a start-up exclusive license to practice the inventions embodied in: US provisional Applications 61/639,688 (E-294-2011/0-US-01) filed April 27, 2012 and PCT application PCT/US2013034639 (E-294-2011/0-PCT-02) filed March 29, 2013, each entitled ``Topical Antibiotic with Immune Stimulating oligodeoxynucleotide Molecules to Speed Wound Healing'' and US application 12/205,756 (E-328-2001/1-US-01) filed September 2008 and issued as US patent 8,466,116, each entitled ``Use of CpG Oligodeoxynucleotides to Induce Epithelial Cell Growth'' to Tollgene having a place of business at 2429 Ginny Way, Lafayette, CO 80026. The patent rights in these inventions have been assigned to the United States of America.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2013 (FY 2014)
This notice updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2013 through September 30, 2014.
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