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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations
recipient if there is sufficient evidence in the medical record of an occurrence of TRALI and the pulmonary edema is not caused by cardiac dysfunction or other causes and occurs within 72 of receiving a blood product containing plasma, in this case VIGIV.
12 Acute renal failure ARF. ARF is the sudden loss of the kidneys ability to perform their main function of eliminating excess fluids and electrolytes salts, as well as waste material from the blood. ARF, which is also called acute kidney injury, develops rapidly over a few hours or a few days. ARF can be fatal and requires intensive treatment; however, ARF may be reversible. ARF may cause permanent loss of kidney function, or end-stage renal disease necessitating dialysis or transplant. A Table 2 injury for ARF has occurred if there is sufficient evidence in the medical record of an occurrence of ARF within the identified timeframe and the individual received the associated countermeasure VIGIV.
13 Drug-induced aseptic meningitis DIAM. i DIAM is an inflammation of the meninges linings of the brain that is not caused by a bacteria or virus, but is caused by a drug or medication. The symptoms of meningitis include severe headache, nuchal neck rigidity, drowsiness, fever, photophobia light sensitivity, painful eye movements, nausea, and vomiting. Discontinuation of the medication leads to a resolution of the symptoms. DIAM is thought to occur because of an immunological hypersensitivity reaction to a specific medication. In the case of immunoglobulins, DIAM may be precipitated by the immunologically active components within the plasma or because of the stabilizers used within the product. The symptoms of DIAM
may reoccur with another exposure to the offending agent.
ii A Table 2 injury for DIAM has occurred in a recipient if there is sufficient evidence in the medical record of an occurrence of DIAM within the identified timeframe and the individual received the associated countermeasure VIGIV. DIAM
occurring in the absence of the use of VIGIV, or DIAM occurring with the use of VIGIV outside the established timeframe of onset, which is any time after the first dose and up to 48 hours after the last dose of this medication, is not a Table 2 injury.
14 Hemolysis. Hemolysis is the physical breakdown of red blood cells RBCs either through natural attrition or as caused by external factors. The RBCs function is to transport oxygen throughout the body in the hemoglobin
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contained within the RBC. Additionally, the RBCs contain the majority of the bodys potassium stores. With hemolysis, the body is unable to transport oxygen effectively, and the person develops hypoxia. Additionally, the rapid breakdown of the cell releases large amounts of potassium into the blood stream, which can cause abnormal heart rhythms and cardiac arrest. In severe cases of hemolysis, a blood transfusion may be required to correct the resulting anemia. A Table 2
injury for hemolysis has occurred if there is sufficient evidence in the medical record of an occurrence of hemolysis, and the patient received the associated countermeasure VIGIV.
Hemolysis occurring in the absence of the use of VIGIV and outside of the timeframe of 12 hours to 14 days after receiving VIGIV is not a Table 2 injury.
Hemolysis occurring from a more likely alternative diagnosis, such as infections, toxins, poisons, hemodialysis, or medications, is not a Table 2 injury.
This list of conditions that can cause hemolysis, not associated with VIGIV, is not exhaustive, and all additional diagnoses within the medical documentation will be evaluated.
FR Doc. 202117216 Filed 81321; 8:45 am BILLING CODE 416515P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management Agency 44 CFR Part 206
Docket ID: FEMA20190012
RIN 1660AB00

Public Assistance Appeals and Arbitrations Federal Emergency Management Agency, DHS.
ACTION: Final rule.
AGENCY:

This final rule implements the new right of arbitration authorized by the Disaster Recovery Reform Act of 2018 DRRA and revises the Federal Emergency Management Agencys regulations regarding first and second Public Assistance appeals.
DATES: This rule is effective on January 1, 2022. Proposed information collection comments must be submitted on or before September 15, 2021.
ADDRESSES: The docket for this rulemaking is available for inspection using the Federal eRulemaking Portal:
http www.regulations.gov and can be SUMMARY:

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viewed by following that websites instructions.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/
PRAMain. Find this particular information collection by selecting Currently under 30-day ReviewOpen for Public Comments or by using the search function.
FOR FURTHER INFORMATION CONTACT:
Shabnaum Amjad, Deputy Associate Chief Counsel, Regulatory Affairs, Office of Chief Counsel, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472. Phone: 202
2122398 or email: Shabnaum.Amjad@
fema.dhs.gov.
SUPPLEMENTARY INFORMATION:
I. Proposed Rule On August 31, 2020, the Federal Emergency Management Agency FEMA published a Notice of Proposed Rulemaking NPRM 85 FR 53725
proposing to revise its current Public Assistance PA appeals regulation at 44
CFR 206.206 to add in the new right to arbitration under the Disaster Recovery Reform Act of 2018 DRRA,1 in conjunction with some revisions to the current appeals process. The DRRA
adds arbitration as a permanent alternative to a second appeal under the PA Program. Additionally, applicants that have had a first appeal pending with FEMA for more than 180 calendar days may withdraw such appeal and submit a request for arbitration. In both cases, the amount in dispute must be greater than $500,000, or greater than $100,000 for an applicant for assistance in a rural area. The other major proposed revisions to 44 CFR 206.206
included adding definitions; adding subparagraphs to clarify what actions FEMA may take and will not take while an appeal is pending and stating that FEMA may issue separate guidance as necessary, similar to current 44 CFR
206.209m; adding a finality of decision paragraph; requiring electronic submission for appeals and arbitrations documents; and clarifying overall time limits for first and second appeals.
These proposed rules for arbitration are separate and distinct from the arbitration provisions located in 44 CFR
206.209. Under 206.209, applicants may request arbitration to resolve disputed PA applications under major disaster declarations for Hurricanes Katrina and Rita, pursuant to the 1 Disaster Recovery Reform Act of 2018, Public Law 115254, 132 Stat. 3186 Oct. 5, 2018, 42
U.S.C. 5189a.

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