Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Document Number: 2016-12053
Type: Notice
Date: 2016-05-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-12043
Type: Notice
Date: 2016-05-23
Agency: Department of Health and Human Services
The Presidential Advisory Council on Combating Antibiotic- Resistant Bacteria (Advisory Council) requests information from the general public and stakeholders related to efforts and strategies to combat antibiotic-resistance. In the process of developing their report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, the Advisory Council followed the framework of the National Action Plan for Combating Antibiotic Resistant Bacteria (Action Plan) to hear about a wide range of ongoing and planned activities by the federal government, including some stakeholders/sectors relevant to this overall effort. This Request for Information (RFI) offers the opportunity for interested individuals, organizations, associations, industries, and others, to provide their feedback. Responses to the questions must be received by 11:59 p.m. on June 22, 2016 to be considered. The questions are also available through an online form on the Advisory Council Web page at www.hhs.gov/ ash/carb. Individuals who wish to send in their responses via email should send an email to CARB@hhs.gov, indicating the question number(s) for which they are responding.
Document Number: 2016-12026
Type: Proposed Rule
Date: 2016-05-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of April 25, 2016. In the proposed rule, FDA requested comments for a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior (SIB or AB). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Document Number: 2016-12023
Type: Notice
Date: 2016-05-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-12022
Type: Notice
Date: 2016-05-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-12010
Type: Notice
Date: 2016-05-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-12009
Type: Notice
Date: 2016-05-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population.
Document Number: 2016-12008
Type: Notice
Date: 2016-05-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed National Health and Nutrition Examination Survey (NHANES) Longitudinal StudyFeasibility Component. This project will provide a logistical test of proposed survey procedures along with contact, interview, and examination rates for a sample of previously examined NHANES participants. The information obtained will be used to determine the feasibility of conducting future follow-up surveys.
Document Number: 2016-11950
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of an extension in the amount of $150,000 for the Maternal and Child Health Collaborative Office Rounds (MCH-COR) grants. The purpose of the program is to foster joint pediatrics-child psychiatry continuing education in the psychosocial development aspects of child health, utilizing a study group approach that emphasizes the practical challenges confronted by community based practitioners. The extension will permit recipients to continue activities within the scope of the current award while the program is evaluated, during the budget period of 7/1/2016-6/30/2017.
Document Number: 2016-11949
Type: Notice
Date: 2016-05-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the summer meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2016. It also announces that the Panel will begin meeting once a year in the summer, beginning in Calendar Year 2017. Currently, the Panel convenes twice yearly. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights and hospital outpatient therapeutic services supervision issues.
Document Number: 2016-11903
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11902
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11901
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11900
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11869
Type: Notice
Date: 2016-05-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2016-11866
Type: Proposed Rule
Date: 2016-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho-phthalates.
Document Number: 2016-11856
Type: Notice
Date: 2016-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Document Number: 2016-11855
Type: Notice
Date: 2016-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist sponsors in designing a clinical development program for new drug products for the treatment of chronic obstructive pulmonary disease (COPD). This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George's Respiratory Questionnaire (SGRQ).
Document Number: 2016-11854
Type: Notice
Date: 2016-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Document Number: 2016-11853
Type: Notice
Date: 2016-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2015.
Document Number: 2016-11846
Type: Notice
Date: 2016-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).'' The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease.
Document Number: 2016-11804
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Bliss and Laughlin Steel in Buffalo, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Document Number: 2016-11791
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-11790
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2016-11785
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0945-0003, scheduled to expire on January 1, 2017. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Document Number: 2016-11776
Type: Notice
Date: 2016-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2018.
Document Number: 2016-11774
Type: Notice
Date: 2016-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 13, 2018.
Document Number: 2016-11773
Type: Notice
Date: 2016-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 31, 2018.
Document Number: 2016-11772
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11771
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11770
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following Patents and Patent Applications to Etubics Corporation (``Etubics'') located in San Francisco, California, USA.
Document Number: 2016-11769
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Option License Agreement to IntelliPanel Medical, LLC, a company having a place of business in Philadelphia, PA, to practice the inventions embodied in the following patent applications:
Document Number: 2016-11757
Type: Notice
Date: 2016-05-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0945-0004, scheduled to expire on May 31, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Document Number: 2016-11731
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-11678
Type: Notice
Date: 2016-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Document Number: 2016-11674
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2016-11672
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2016-11663
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11662
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-11661
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to practice the inventions embodied in the following patent applications to Chimeron Bio Corporation, a company incorporated under the laws of Delaware and having an office in Philadelphia, PA. Intellectual Property: U.S. Provisional Patent Application No.: 61/ 615,687 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-01 Filed March 26, 2012; International Patent Application No.: PCT/US2013/031876 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-PCT-02 Filed March 15, 2013; Australian Patent Application No.: 2013-240248 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264- 2011/0-AU-03 Filed October 17, 2014; European Patent Application No.: 13712661.1 Entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-EP-04 Filed October 24, 2014; Japanese Patent Application No.: 2015-503322 entitled ``Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-JP-05 Filed September 25, 2014; U.S. Patent Application No.: 14/388,441 Entitled Delivery of Packaged RNA in Mammalian Cells'' HHS Ref. No.: E-264-2011/0-US-06 Filed September 26, 2014; U.S. Provisional Patent Application No.: 61/ 916,394 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP- Replicon'' HHS Ref. No.: E-050-2014/0-US-01 Filed December 16, 2013; International Patent Application No.: PCT/US2014/070552 Entitled ``Cancer Immunotherapy: Delivery HLA-11 using VLP-Replicon'' HHS Ref. No.: E-050-2014/0-PCT-02 Filed December 16, 2014; The patent rights to these inventions have been assigned to the Government of the United States of America. The prospective exclusive start-up licensed territory may be worldwide and the field of use may be limited to: ``Use of virus like particles comprising MHCII and CD80 for the treatment of breast cancer, lung cancer, melanoma, pancreatic cancer, and hepatocellular cancer.''
Document Number: 2016-11660
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property U.S. Provisional Patent Application 61/654,232 entitled ``High- affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-US-01]; PCT Patent Application PCT/US2013/043633 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-PCT-02]; Chinese Patent Application 201380039993.7 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03]; Japanese Patent Application 2015-515243 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP- 04]; South Korea Patent Application 10-2014-7037046 entitled ``High- affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-KR-05]; Singapore Patent Application 11201407972R entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-SG-06]; United States Patent Application 14/403,896 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-US-07];
Document Number: 2016-11659
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: Intellectual Property: U.S. Provisional Patent Application 61/ 654,232 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-US-01]; PCT Patent Application PCT/US2013/043633 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-PCT-02]; Chinese Patent Application 201380039993.7 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN- 03]; Japanese Patent Application 2015-515243 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136- 2012/0-JP-04]; South Korea Patent Application 10-2014-7037046 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-KR-05]; Singapore Patent Application 11201407972R entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-SG-06]; United States Patent Application 14/403,896 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136- 2012/0-US-07]; and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ``The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) the complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.''
Document Number: 2016-11658
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 8, 2016 page 12111 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Document Number: 2016-11657
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2016-11633
Type: Notice
Date: 2016-05-18
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-11458
Type: Rule
Date: 2016-05-18
Agency: Department of Health and Human Services, Office of the Secretary
This final rule implements Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. The final rule clarifies and codifies existing nondiscrimination requirements and sets forth new standards to implement Section 1557, particularly with respect to the prohibition of discrimination on the basis of sex in health programs other than those provided by educational institutions and the prohibition of various forms of discrimination in health programs administered by the Department of Health and Human Services (HHS or the Department) and entities established under Title I of the ACA. In addition, the Secretary is authorized to prescribe the Department's governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities.
Document Number: 2016-11618
Type: Notice
Date: 2016-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 19, 2016, and page numbers 8514-8516, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674- 14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., DC, N.D., O.D., D.V.M., or equivalent degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one or two-year renewal application. Affected Public: Individuals or households; Nonprofits; and Businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 33,242.
Document Number: 2016-11564
Type: Notice
Date: 2016-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Health Record Data in Clinical Investigations.'' The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.
Document Number: 2016-11560
Type: Notice
Date: 2016-05-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-11556
Type: Notice
Date: 2016-05-17
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
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