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Federal Register/Vol. 84, No. 24/Tuesday, February 5, 2019/Proposed Rules 1678 Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Proposed Rules and complete to the best of the DEPARTMENT OF VETERANS which pertains to chronic fatigue individual’s knowledge, information, AFFAIRS syndrome (CFS), and 38 CFR 4.88b, and belief, and is made in good faith. which pertains to the schedule of 38 CFR Part 4 (iii) Submission of an opt-out notice ratings for infectious diseases and immune disorders (we note that the does not constitute agreement by the RIN 2900–AQ43 proposed changes for § 4.88b exclude rights owner or the individual the schedule of ratings for nutritional submitting the opt-out notice that the Schedule for Rating Disabilities: Infectious Diseases, Immune deficiencies—diagnostic codes (DC) proposed use is in fact noncommercial. Disorders, and Nutritional Deficiencies 6313, 6314, and 6315). VA last updated The submitter may choose to comment the schedule of ratings in § 4.88b on July upon whether the rights owner agrees AGENCY: Department of Veterans Affairs. 31, 1996 (see 61 FR 39875) and updated that the proposed use is noncommercial ACTION: Proposed rule. § 4.88a on July 19, 1995 (see 60 FR use, but failure to do so does not 37012). constitute agreement that the proposed SUMMARY: The Department of Veterans VA proposes to: (1) Update the use is in fact noncommercial. Affairs (VA) proposes to amend the medical terminology and definition of section of the VA Schedule for Rating (3) Multiple rights owners. Where a certain infectious diseases and immune Disabilities (VASRD or Rating Schedule) disorders; (2) add medical conditions pre-1972 sound recording has multiple that addresses infectious diseases and rights owners, only one rights owner not currently in the Rating Schedule; (3) immune disorders. The purpose of these refine evaluation criteria based on needs to file an opt-out notice for changes is to incorporate medical medical advances that have occurred purposes of 17 U.S.C. 1401(c)(5). advances since the last revision, update since the last revision; and (4) (4) Effect of opting out. If a rights medical terminology, and clarify incorporate current understanding of owner files a timely opt-out notice evaluation criteria. The proposed rule functional changes associated with or under paragraph (e)(1) of this section, considers comments from experts and resulting from disease the user must wait one year before filing the public during a forum held from (pathophysiology). another notice of noncommercial use January 31 to February 1, 2011, on A panel of independent experts proposing the same or similar use of the revising this section of the VASRD. convened by the Institute of Medicine same pre-1972 sound recording(s). DATES: Comments must be received by (IOM) in February 2015 proposed an VA on or before April 8, 2019. updated set of diagnostic criteria for (5) Legal sufficiency. The Copyright ADDRESSES: Written comments may be infectious disease and immune Office does not review opt-out notices submitted through www.regulations.gov; disorders. This updated revision also submitted under paragraph (e)(1) of this by mail or hand-delivery to Director, included changing the name of CFS to section for legal sufficiency. The Regulation Policy and Management ‘‘Systemic Exertion Intolerance Disease Office’s review is limited to whether the (00REG), Department of Veterans (SEID)/Chronic fatigue Syndrome procedural requirements established by Affairs, 810 Vermont Ave. NW, Room (CFS).’’ the Office (including payment of the 1063B, Washington, DC 20420; or by fax VA has clear authority to make this proper filing fee) have been met. Rights to (202) 273–9026. (This is not a toll free regulatory change because of its broad owners are therefore cautioned to number.) Comments should indicate authority to ‘‘prescribe all rules and review and scrutinize opt-out notices to that they are submitted in response to regulations which are necessary or assure their legal sufficiency before ‘‘RIN 2900–AQ43—Schedule for Rating appropriate to carry out the laws submitting them to the Office. Disabilities: Infectious Diseases, administered by [VA] and are consistent with those laws.’’ 38 U.S.C. 501(a); see (6) Filing date. The date of filing of an Immune Disorders, and Nutritional also 38 U.S.C. 1155 (VA’s authority to opt-out notice is the date when a proper Deficiencies.’’ Copies of comments received will be available for public adopt and apply schedule for rating submission, including the prescribed disabilities). fee, is received in the Copyright Office. inspection in the Office of Regulation Policy and Management, Room 1063B, § 4.88a Chronic Fatigue Syndrome (7) Fee. The filing fee to submit an between the hours of 8 a.m. and 4:30 Currently, § 4.88a specifies older opt-out notice pursuant to this section is p.m., Monday through Friday (except diagnostic criteria for the diagnosis of prescribed in § 201.3(c). holidays). Please call (202) 461–4902 for CFS and uses outdated terminology to an appointment. (This is not a toll free (f) Fraudulent filings. If the Register refer to this complex disease. VA number.) In addition, during the becomes aware of abuse or fraudulent proposes to update the nomenclature for comment period, comments may be filings under this section by or from a this disease, which is also known as viewed online through the Federal certain filer or user, she shall have the systemic exertion intolerance disease Docket Management System (FDMS) at discretion to reject all submissions from (SEID) or myalgic encephalomyelitis www.Regulations.gov. that filer or user under this section for (ME), by changing the diagnostic code up to one year. FOR FURTHER INFORMATION CONTACT: name to ‘‘Systemic Exertion Intolerance Ioulia Vvedenskaya, M.D., M.B.A., Dated: January 30, 2019. Disease (SEID)/Chronic Fatigue Medical Officer, Part 4 VASRD Regan A. Smith, Syndrome (CFS).’’ This new name Regulations Staff (211C), Compensation captures a central characteristic of the General Counsel and Associate Register of Service, Veterans Benefits disease that reflects negative effects of Copyrights. Administration, Department of Veterans any exertion (physical, cognitive, or [FR Doc. 2019–00873 Filed 2–4–19; 8:45 am] Affairs, 810 Vermont Avenue NW, emotional) on patients’ many organ BILLING CODE 1410–30–P Washington, DC 20420, (202) 461–9700. systems. IOM (Institute of Medicine), (This is not a toll-free telephone Beyond Myalgic Encephalomyelitis/ number.) Chronic Fatigue Syndrome: Redefining SUPPLEMENTARY INFORMATION: As part of an Illness (2015), http://www.national its ongoing revision of the VASRD, VA academies.org/hmd/∼/media/Files/ proposes changes to 38 CFR 4.88a, Report%20Files/2015/ VerDate Sep<11>2014 16:34 Feb 04, 2019 Jkt 247001 PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 E:\FR\FM\05FEP1.SGM 05FEP1 Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Proposed Rules 1679 MECFS/MECFScliniciansguide.pdf (last principles are generally consistent with evaluation. However, even though accessed August 30, 2018). the clinical presentation of infectious advancements in antimicrobial therapy VA is also proposing to revise the diseases. have significantly lessened the current diagnostic criteria for SEID/CFS VA proposes one General Rating occurrence of residuals of infectious to adhere to evidence-based criteria Formula for § 4.88b. This approach is diseases, they continue to occur. which were adopted by the Centers for based on the association between Therefore, VA generally proposes to Disease Control and Prevention (CDC). clinical resolution or stabilization of an append each diagnostic code with a IOM Report on ME/CFS (2015) (updated infectious disease and elimination or note describing the most common July 3, 2017), https://www.cdc.gov/me- complete suppression of the causative residuals associated with a given cfs/symptoms-diagnosis/diagnosis.html infectious agent. Regardless of whether infection. See below for additional (last accessed July 17, 2018). According resolution occurs spontaneously or details. As a list of every residual would to the 2015 IOM Report, up to 2.5 because of treatment, long-term be impractical, these notes would million Americans suffer from this disability in such situations results from clearly indicate that they are not disease which is characterized by residual functional impairment of the exhaustive. Where ascertainable profound fatigue, cognitive dysfunction, body systems affected by the infectious residuals exist, VA proposes to assign sleep abnormalities, pain, autoimmune disease, rather than the infection itself. evaluations for those residuals under manifestations, and a variety of other Sheila Davey, World Health the appropriate body system(s). symptoms that are made worse by Organization, World Health Certain infectious conditions are exertion of any sort. New diagnostic Organization Report on Infectious prone to relapse and require laboratory criteria will take into consideration Diseases: Removing Obstacles to evaluation for confirmation. L. Joseph whether this severe chronic fatigue Healthy Development (1999). Wheat et al., Clinical Practice significantly interferes with daily Therefore, VA’s proposal to use a Guidelines for the Management of activities and work, if the affected General Rating Formula does not Patients with Histoplasmosis: 2007 individual concurrently has four or substantively change the current Update by the Infectious Diseases more of the eight symptoms as outlined evaluation criteria so much as their Society of America, 45 Clinical in CDC evidence-based criteria and organization. This rulemaking proposes Infectious Diseases 807, 807–25 (2007). whether these symptoms first appeared to restructure rating criteria by creating Oftentimes, non-specific constitutional before the fatigue, have persisted or one General Rating Formula applicable symptoms (weakness, tiredness, recurred during six or more consecutive to multiple infectious diseases, insomnia, weight loss, etc.) occur months of illness, and were due to regardless of etiology. A General Rating following the active phase of an ongoing exertion or other medical Formula for infectious diseases would infectious disease. However, such conditions associated with fatigue.
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