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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Authority of Health Care Providers To Practice TelehealthProposed Rule2017-2095110/02/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) proposes to amend its medical regulations by standardizing the delivery of care by VA health care providers through telehealth. This rule would ensure that VA health care providers provide the sa … The Department of Veterans Affairs (VA) proposes to amend its medical regulations by standardizing the delivery of care by VA health care providers through telehealth. This rule would ensure that VA health care providers provide the same level of care to all beneficiaries, irrespective of the State or location in a State of the VA health care provider or the beneficiary. This proposed rule would achieve important Federal interests by increasing the availability of mental health, specialty, and general clinical care for all beneficiaries.authority-of-health-care-providers-to-practice-telehealthFR-Doc-2017-20951
Humanitarian Use Devices; 21st Century Cures Act; Technical AmendmentRule2017-1181606/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institut … The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.humanitarian-use-devices-21st-century-cures-act-technical-amendmentFR-Doc-2017-11816
Use of Medicare Procedures To Enter Into Provider Agreements for Extended Care ServicesProposed Rule2017-0944905/10/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) published a notice of proposed rulemaking in the Federal Register on February 13, 2013, that proposed amending its regulations to allow VA to enter into provider agreements to obtain extende … The Department of Veterans Affairs (VA) published a notice of proposed rulemaking in the Federal Register on February 13, 2013, that proposed amending its regulations to allow VA to enter into provider agreements to obtain extended care services for Veterans from community providers. Since publication of that proposed rule, further review has led VA to conclude VA cannot achieve the proposal's goals without a statutory change. For this reason, VA withdraws the proposed rule.use-of-medicare-procedures-to-enter-into-provider-agreements-for-extended-care-servicesFR-Doc-2017-09449
Payment or Reimbursement for Certain Medical Expenses for Camp Lejeune Family MembersRule2017-0916305/05/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) adopts as final an interim final rule addressing payment or reimbursement of certain medical expenses for family members of Camp Lejeune veterans. Under this rule, VA reimburses family members, … The Department of Veterans Affairs (VA) adopts as final an interim final rule addressing payment or reimbursement of certain medical expenses for family members of Camp Lejeune veterans. Under this rule, VA reimburses family members, or pays providers, for medical expenses incurred as a result of certain illnesses and conditions that may be associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953, to December 31, 1987. Payment or reimbursement is made within the limitations set forth in statute and Camp Lejeune family members receive hospital care and medical services that are consistent with the manner in which we provide hospital care and medical services to Camp Lejeune veterans. The statutory authority has since been amended to also include certain veterans' family members who resided at Camp Lejeune, North Carolina, for no less than 30 days (consecutive or nonconsecutive) between August 1, 1953, and December 31, 1987. This final rule will reflect that statutory change and will address public comments received in response to the interim final rule.payment-or-reimbursement-for-certain-medical-expenses-for-camp-lejeune-family-membersFR-Doc-2017-09163
Fertility Counseling and Treatment for Certain Veterans and Spouses, CorrectionRule2017-0331902/21/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs published in the Federal Register on January 19, 2017, an interim final rulemaking adding a new section authorizing in vitro fertilization (IVF) for a veteran with a service-connected disability … The Department of Veterans Affairs published in the Federal Register on January 19, 2017, an interim final rulemaking adding a new section authorizing in vitro fertilization (IVF) for a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. In addition, we added a new section authorizing VA to provide fertility counseling and treatment using assisted reproductive technologies (ART), including IVF, to a spouse of a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. These sections contain an error regarding the expiration date VA's authority to provide health care services. This document corrects the errors and does not make any substantive change to the content of the interim final rule.fertility-counseling-and-treatment-for-certain-veterans-and-spouses-correctionFR-Doc-2017-03319
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin RegulationsRule2017-0085701/19/2017DEPARTMENT OF AGRICULTUREAgriculture DepartmentIn accordance with the Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or … In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action will amend the regulations in several ways, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes will increase the usability of the select agent regulations as well as providing for enhanced program oversight. After carefully considering the technical input of subject matter experts and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the contents of the list of select agents and toxins at this time. In a companion document published in this issue of the Federal Register, the Centers for Disease Control and Prevention has made parallel regulatory changes.agricultural-bioterrorism-protection-act-of-2002-biennial-review-and-republication-of-the-selectFR-Doc-2017-00857
Fertility Counseling and Treatment for Certain Veterans and SpousesRule2017-0028001/19/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) amends its regulation regarding fertility counseling and treatment available to certain veterans and spouses. VA currently provides certain infertility services other than in vitro fertilization … The Department of Veterans Affairs (VA) amends its regulation regarding fertility counseling and treatment available to certain veterans and spouses. VA currently provides certain infertility services other than in vitro fertilization (IVF) to veterans as part of the medical benefits package. IVF is the process of fertilization by manually fertilizing an egg, and then transferring the embryo to the uterus. This interim final rulemaking adds a new section authorizing IVF for a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. In addition, we add a new section stating that VA may provide fertility counseling and treatment using assisted reproductive technologies (ART), including IVF, to a spouse of a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. VA will provide ART treatment, including IVF, to these veterans and spouses as specified in the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act to the extent such services are consistent with the services available to enrolled veterans under the medical benefits package.fertility-counseling-and-treatment-for-certain-veterans-and-spousesFR-Doc-2017-00280
Repayment by VA of Educational Loans for Certain Psychiatrists; CorrectionRule2017-0023201/17/2017DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs published in the Federal Register on September 29, 2016, a document amending its regulations concerning the repayment of educational loans for certain psychiatrists who agree to a period of obligated … The Department of Veterans Affairs published in the Federal Register on September 29, 2016, a document amending its regulations concerning the repayment of educational loans for certain psychiatrists who agree to a period of obligated service with VA. The document contained several section and paragraph numbering errors. This document corrects the errors and does not make any substantive change to the content of the final rule.repayment-by-va-of-educational-loans-for-certain-psychiatrists-correctionFR-Doc-2017-00232
Advanced Practice Registered NursesRule2016-2995012/14/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) is amending its medical regulations to permit full practice authority of three roles of VA advanced practice registered nurses (APRN) when they are acting within the scope of their VA em … The Department of Veterans Affairs (VA) is amending its medical regulations to permit full practice authority of three roles of VA advanced practice registered nurses (APRN) when they are acting within the scope of their VA employment. Certified Registered Nurse Anesthetists (CRNA) will not be included in VA's full practice authority under this final rule, but comment is requested on whether there are access issues or other unconsidered circumstances that might warrant their inclusion in a future rulemaking. The final rulemaking establishes the professional qualifications an individual must possess to be appointed as an APRN within VA, establishes the criteria under which VA may grant full practice authority to an APRN, and defines the scope of full practice authority for each of the three roles of APRN. The services provided by an APRN under full practice authority in VA are consistent with the nursing profession's standards of practice for such roles. This rulemaking increases veterans' access to VA health care by expanding the pool of qualified health care professionals who are authorized to provide primary health care and other related health care services to the full extent of their education, training, and certification, without the clinical supervision of physicians, and it permits VA to use its health care resources more effectively and in a manner that is consistent with the role of APRNs in the non-VA health care sector, while maintaining the patient-centered, safe, high-quality health care that veterans receive from VA.advanced-practice-registered-nursesFR-Doc-2016-29950
Extension of Pharmacy Copayments for MedicationsRule2016-2933712/07/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) amends its medical regulations concerning the copayment required for certain medications. This rulemaking freezes copayments at the current rate for veterans in priority groups 2 through 8 through February 26, 2017.The Department of Veterans Affairs (VA) amends its medical regulations concerning the copayment required for certain medications. This rulemaking freezes copayments at the current rate for veterans in priority groups 2 through 8 through February 26, 2017.extension-of-pharmacy-copayments-for-medicationsFR-Doc-2016-29337
Medical Devices; Custom Devices; Technical AmendmentRule2016-2443810/12/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Ac … The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.medical-devices-custom-devices-technical-amendmentFR-Doc-2016-24438
Repayment by VA of Educational Loans for Certain PsychiatristsRule2016-2336009/29/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) is adding to its medical regulations a program for the repayment of educational loans for certain psychiatrists who agree to a period of obligated service with VA. This program is intended to i … The Department of Veterans Affairs (VA) is adding to its medical regulations a program for the repayment of educational loans for certain psychiatrists who agree to a period of obligated service with VA. This program is intended to increase the pool of qualified VA psychiatrists and increase veterans' access to mental health care.repayment-by-va-of-educational-loans-for-certain-psychiatristsFR-Doc-2016-23360
Clinical Trials Registration and Results Information SubmissionRule2016-2212909/21/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device produc … This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.clinical-trials-registration-and-results-information-submissionFR-Doc-2016-22129
Telephone Enrollment in the VA Healthcare SystemRule2016-2183009/12/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) adopts as final, without change, an interim final rule amending its medical regulations. Specifically, this rule allows veterans to complete applications for health care enrollment by pr … The Department of Veterans Affairs (VA) adopts as final, without change, an interim final rule amending its medical regulations. Specifically, this rule allows veterans to complete applications for health care enrollment by providing application information, agreeing to VA's provisions regarding copayment liability and assignment of third-party insurance benefits, and attesting to the accuracy and authenticity of the information provided to a VA employee over the phone. This action makes it easier for veterans to apply to enroll and speeds VA processing of applications.telephone-enrollment-in-the-va-healthcare-systemFR-Doc-2016-21830
Disqualification of a Clinical InvestigatorProposed Rule2016-1987608/24/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical … The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.disqualification-of-a-clinical-investigatorFR-Doc-2016-19876
Hospital Care and Medical Services for Camp Lejeune VeteransRule2016-1691707/18/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThis document amends Department of Veterans Affairs (VA) regulations to reflect a statutory mandate that VA provide health care to certain veterans who served at Camp Lejeune, North Carolina, for at least 30 days during the period beg … This document amends Department of Veterans Affairs (VA) regulations to reflect a statutory mandate that VA provide health care to certain veterans who served at Camp Lejeune, North Carolina, for at least 30 days during the period beginning on August 1, 1953, and ending on December 31, 1956. The law requires VA to furnish hospital care and medical services for these veterans for certain illnesses and conditions that may be attributed to exposure to toxins in the water system at Camp Lejeune. This rule does not address the statutory provision requiring VA to provide health care to these veterans' family members; regulations applicable to such family members will be promulgated through a separate final rule.hospital-care-and-medical-services-for-camp-lejeune-veteransFR-Doc-2016-16917
Advanced Practice Registered NursesProposed Rule2016-1233805/25/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThe Department of Veterans Affairs (VA) is proposing to amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employme … The Department of Veterans Affairs (VA) is proposing to amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. This rulemaking would increase veterans' access to VA health care by expanding the pool of qualified health care professionals who are authorized to provide primary health care and other related health care services to the full extent of their education, training, and certification, without the clinical supervision of physicians. This rule would permit VA to use its health care resources more effectively and in a manner that is consistent with the role of APRNs in the non-VA health care sector, while maintaining the patient-centered, safe, high-quality health care that veterans receive from VA. The proposed rulemaking would establish additional professional qualifications an individual must possess to be appointed as an APRN within VA. The proposed rulemaking would subdivide APRN's into four separate categories that include certified nurse practitioner, certified registered nurse anesthetist, clinical nurse specialist, and certified nurse-midwife. The proposed rulemaking would also provide the criteria under which VA may grant full practice authority to an APRN, and define the scope of full practice authority for each category of APRN. VA intends that the services to be provided by an APRN in one of the four APRN roles would be consistent with the nursing profession's standards of practice for such roles.advanced-practice-registered-nursesFR-Doc-2016-12338
Health Care for Certain Children of Vietnam Veterans and Certain Korea Veterans-Covered Birth Defects and Spina BifidaRule2016-0789704/06/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThis rule adopts as final a proposed rule of the Department of Veterans Affairs (VA) to amend its regulations concerning the provision of health care to birth children of Vietnam veterans and veterans of covered service in Korea d … This rule adopts as final a proposed rule of the Department of Veterans Affairs (VA) to amend its regulations concerning the provision of health care to birth children of Vietnam veterans and veterans of covered service in Korea diagnosed with spina bifida, except for spina bifida occulta, and certain other birth defects. In the proposed rule published on May 15, 2015, VA proposed changes to more clearly define the types of health care VA provides, including day health care and health-related services, which we defined as homemaker or home health aide services that provide assistance with Activities of Daily Living or Instrumental Activities of Daily Living that have therapeutic value. We also proposed changes to the list of health care services that require preauthorization by VA. This final rule addresses comments received from the public and adopts as final the proposed rule, without change.health-care-for-certain-children-of-vietnam-veterans-and-certain-korea-veterans-covered-birthFR-Doc-2016-07897
Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical AmendmentRule2016-0688603/28/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluatio … The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.investigational-new-drug-applications-for-biological-products-bioequivalence-regulations-technicalFR-Doc-2016-06886
Telephone Enrollment in the VA Healthcare SystemRule2016-0568003/16/2016DEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentThis rulemaking amends VA's medical regulations to allow veterans to complete applications for health care enrollment by telephone by providing application information to a VA employee, agreeing to VA's provisions regarding copa … This rulemaking amends VA's medical regulations to allow veterans to complete applications for health care enrollment by telephone by providing application information to a VA employee, agreeing to VA's provisions regarding copayment liability and assignment of third-party insurance benefits, and attesting to the accuracy and authenticity of the information provided over the phone. This action will make it easier for veterans to apply to enroll and will speed VA processing of applications.telephone-enrollment-in-the-va-healthcare-systemFR-Doc-2016-05680
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