Department of Health and Human Services April 2014 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 323
Eastman Chemical Company; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Eastman Chemical Company, proposing that the food additive regulations be amended to remove the upper bound of the melting point range in the regulation for the antioxidant TBHQ (tertiary butylhydroquinone) and add a purity acceptance criterion.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the April meeting, the Advisory Council will hear presentations from the three subcommittees (Research, Clinical Care, and Long-Term Services and Supports). The Advisory Council will hear updates to the 2014 plan. The Advisory Council will also hear presentations on state and local plans to address dementia.
Privacy Act of 1974, Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new SOR titled, ``Hospice Item Set (HIS) System,'' System No. 09-70-0548. The new system will support the collection of data required for the Hospice Quality Reporting Program (HQRP) pursuant to Section 3004(c) of the Patient Protection and Affordable Care Act of 2010 (ACA) (Pub. L. 111-148), which amended the Social Security Act (the Act) (42 U.S.C. 1814(i)). HIS is a standardized, patient-level data collection vehicle consisting of data elements confirming that the appropriate assessments were made and inquiries or concerns were addressed for each patient at the time of admission for the following domains of care: (1) Pain; (2) Respiratory Status; (3) Medications; (4) Patient Preferences; and (5) Beliefs & Values.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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 proposed extension of the collection of information concerning requirements relating to FDA's Adverse Experience Reporting System (AERS) for licensed biological products, and general records associated with the manufacture and distribution of biological products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension
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 burden hours associated with indexing of legal marketed unapproved new animal drugs for minor species.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
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 a generic clearance to collect information to support communications used by FDA about drug products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
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 ``Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use, and also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing devices.
Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction
The Food and Drug Administration (FDA) published a document in the Federal Register of February 27, 2014, concerning the voluntary withdrawal of approval of new animal drug applications (NADAs). The document contained an incorrect list of NADAs.
Determination That SKELAXIN (Metaxalone) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that SKELAXIN (metaxalone) Tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SKELAXIN (metaxalone) Tablets, 400 mg, if all other legal and regulatory requirements are met.
Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the report and Web site location where the Agency has posted the report entitled ``Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework.'' In addition, FDA has established a docket where stakeholders may provide comments.
Determination of Regulatory Review Period for Purposes of Patent Extension; MELAFIND SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for MELAFIND SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
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 allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for manufacturers of Type A medicated articles.
Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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 recordkeeping requirements for manufacturers of medicated animal feeds.
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.
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.
Opportunity To Co-sponsor an AHRQ Research Conference
AHRQ announces the opportunity for non-Federal public and private sector entities to co-sponsor an AHRQ conference in the Washington, DC area in early March, 2015. Potential co-sponsors must have a demonstrated interest and experience in health services research, implementation, and evaluation. Potential co-sponsors must also be capable of sponsoring and managing various discrete sessions or events associated with the conference and be willing to participate substantively in the co-sponsored activity.
Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act.'' The guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled ``Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.''
Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.'' This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need To Know About Establishment, Maintenance, and Availability of Records Small Entity Compliance Guide'' (SECG), which updates an earlier guidance of the same title. Previously, this guidance restated the legal requirements of FDA's maintenance and establishment of records regulation and served as that regulation's SECG. Because the FDA Food Safety Modernization Act (FSMA) amended FDA's maintenance and establishment of records regulation, FDA issued an interim final rule (IFR) amending certain regulations to be consistent with the changes. Accordingly, FDA is revising this guidance to help any entity comply with FDA's maintenance and establishment of records requirements, including the amendments to these requirements made by the IFR as finalized. This guidance continues to serve as FDA's SECG.
Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review and other additional types of communication, to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process.
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.
Request for Nominations: Advisory Committee on Training in Primary Care Medicine and Dentistry
The Health Resources and Services Administration (HRSA) is requesting nominations to fill eight vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD).
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.
Notice of Supplemental Funding Opportunity
Funded in part by the Secretary's Minority AIDS Initiative Fund (SMAIF), as set forth in the Consolidated Appropriations Act of 2014, Public Law 113-76, H.R. 3547-376, a supplemental funding opportunity will be available in June 2014, for certain existing Health Center Program grantees funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b). This supplemental funding opportunity is one facet of a partnership between the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration, Bureau of Primary Health Care (HRSA, BPHC), which will encourage collaboration between Health Center Program grantees in geographic areas of high HIV/AIDS unmet need among racial/ ethnic minorities and state health departments to increase and improve HIV service delivery within their primary care programs. Under Secretary's Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions (CDC-RFA-PS14-1410), CDC will fund approximately four state health departments through a competitive application process among nine state health departments (Alabama, California, Florida, Maryland, Massachusetts, Michigan, New York, South Carolina, and Texas) that have been identified as eligible to apply for funding. State health department awardees must collaborate with Health Center Program grantees identified in their applications to increase and improve HIV service delivery among racial/ethnic minorities. Health Center Program grantees identified in awarded health department applications may subsequently apply for supplemental funding from HRSA for their participation in this collaboration. HRSA will award 12-24 supplemental awards ranging in amount from $250,000 to $500,000 to existing Health Center Program grantees identified by state health departments as collaborative partners in their applications for grant funding under Secretary's Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions (CDC- RFA-PS14-1410). This supplemental funding will support activities currently in scope of health center projects, including health center workforce development, infrastructure development, HIV service delivery across the HIV care continuum, and the development of sustainable partnerships with state health departments.
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, HHS 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 0955-0005, which expires on July 31, 2014. 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.
The Meaning of “Spouse” and “Family” in the Food and Drug Administration's Regulations After the Supreme Court's Ruling in United States v. Windsor-Questions and Answers: Guidance for Industry, Consumers, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``The Meaning of `Spouse' and `Family' in FDA's Regulations after the Supreme Court's Ruling in United States v. WindsorQuestions and Answers: Guidance for Industry, Consumers, and FDA Staff.'' This guidance informs the public of FDA's interpretation of the effects of the Supreme Court's decision in United States v. Windsor on several of its regulations. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate.
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, 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 the ICR to OMB, the Office of the Secretary seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
60-Day Notice for Extension of Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
HHS, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery, This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection,
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for more than 200 persons living with HIV/AIDS, HRSA will provide a one- time noncompetitive Ryan White HIV/AIDS Program Part C award to St. Luke's Hospital, Bethlehem, Pennsylvania.
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.
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Proposed Collection; 60-Day Comment Request; Recruitment and Screening for the Insight Into Determination of Exceptional Aging and Longevity (IDEAL) Study (NIA)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Luigi Ferrucci, M.D., Ph.D., NIA Clinical Research Branch, Harbor Hospital, 5th Floor 3001 S. Hanover, Baltimore, MD 21225 or call non-toll-free number (410) 350-3936 or Email your request, including your address to: Ferruccilu@grc.nia.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study(0925- 0631). Reinstatement with ChangeNational Institute on Aging (NIA), National Institutes of Health (NIH). Need and Use of Information Collection: Longevity combined with good health and functionality at the end of life represents a common goal. Although research has examined correlates of long life and functional decline, we still know relatively little about why certain individuals live in excellent health into their eighties while others succumb to failing health at much younger ages. Understanding the mechanisms important to ideal aging may provide new opportunity for health promotion and disability prevention is this rapidly growing segment of the population. The purpose of IDEAL (Insight into the Determinants of Exceptional Aging and Longevity) is to recruit into the Baltimore Longitudinal Study on Aging (BLSA) exceptionally long lived and healthy individuals and to learn what makes them so resilient and resistant to disease and disability, and to identify potential interventions that may contribute to the IDEAL condition. By enrolling the IDEAL cohort in the BLSA their biologic, physiologic, behavioral and functional characteristics will be evaluated using the same methods used with the current cohort who will serve as a type of control group. The first aim is to identify factors and characteristics that distinguish IDEAL from non-IDEAL individuals. We intend to compare the two groups to identify factors that discriminate IDEAL aging from non-IDEAL aging individuals. The second aim is to identify physiological, environmental and behavioral characteristics that are risk factors for losing the IDEAL condition over several years or longer. We postulate that the mechanisms of extreme longevity probably differ from those associated with delay or escape from disease and disability. As is customary in the BLSA, we plan to follow this cohort for life with yearly visits. This is a request for OMB clearance to continue to recruit and screen respondents into the Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study over the next 3 years. OMB approval is requested for 3 years. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 263.
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 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.
Technical Assistance: Senior Legal Helplines and Model Approaches to Statewide Legal Assistance Systems
The Administration for Community Living (ACL) is announcing the application deadline and a single case deviation from maximum competition for Technical Assistance (TA) grants providing support to Senior Legal Helplines (SLH) and Model Approaches to Statewide Legal Assistance Systems (Model Approaches) projects under Section 420(a)(2) of the Older Americans Act (OAA). The two (2) TA grants provide focused resource support specifically to SLHs and Model Approaches demonstration projects involved in improving the quality, cost effectiveness, and accessibility of legal assistance and elder rights protections provided to older people. The purpose of this deviation is to award a 4th year non-competing continuation to TA grants, with a three (3) year budget period set to expire May 31, 2014, so that: (1) Stakeholder input can be obtained on the resource support needs of legal and aging/disability service providers across the country; and (2) the current focus of the TA grants can be better directed to support and advance ACL activities anticipated in FY15 in the area of elder rights and elder abuse prevention. Program Name: National Legal Assistance and SupportNational Legal Resource Center. Award Amount: $214,636 ($143,000/$71,636 per grantee). Project Period: 6/1/2011 to 5/31/2015. Award Type: Cooperative Agreement.
Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that PREZISTA (darunavir) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 400 mg, if all other legal and regulatory requirements are met.
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