Quiero saber acerca de...

Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations Federal, State, and local officer designated by or assisting the Captain of the Port COTP Sector Guam in the enforcement of the safety zone.
c Regulations. 1 In accordance with the general regulations in section 165.23, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the COTP or a designated on-scene representative.
2 This safety zone is closed to all persons and vessel traffic, except as may be permitted by the COTP or a designated on-scene representative.
3 The on-scene representative of the COTP is any Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP
to act on his or her behalf.
4 Persons and Vessel operators desiring to enter or operate within the safety zone must contact the COTP or an on-scene representative to obtain permission to do so. The COTP or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or an on-scene representative.
d Enforcement period. This safety zone will be enforced at a specified date between February and April. The Coast Guard will provide advance notice of enforcement and a broadcast notice to mariners to inform public of specific date.
Dated: January 12, 2021.
Christopher M. Chase, Captain, U.S. Coast Guard, Captain of the Port, Guam.
FR Doc. 202101084 Filed 11921; 8:45 am BILLING CODE 911004P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Health Service 42 CFR Part 100
RIN 0906AB24

National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table Public Health Service, Health Resources and Services Administration HRSA, Department of Health and Human Services HHS or the Department.
ACTION: Final rule.

jbell on DSKJLSW7X2PROD with RULES

AGENCY:

The Secretary finalizes the proposed rule to amend the Vaccine Injury Table Table by regulation. This
SUMMARY:

VerDate Sep<11>2014

15:40 Jan 19, 2021

Jkt 253001

final rule will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program VICP filed after this final rule become effective. This final rule does not impact COVID19 vaccines or PREP
Act immunity for Covered Persons as defined in the PREP Act who manufacture, distribute, order, or administer COVID19 vaccines.
This final rule is effective on February 22, 2021.

DATES:

FOR FURTHER INFORMATION CONTACT:

Please visit the National Vaccine Injury Compensation Programs website, https www.hrsa.gov/
vaccinecompensation/, or contact Tamara Overby, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at vaccinecompensation@hrsa.gov; or by telephone at 855 2662427.
This is a final rule by which HHS amends the provisions of 42 CFR 100.3 by removing Shoulder Injury Related to Vaccine Administration, vasovagal syncope, and Item XVII from the Vaccine Injury Table.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose Vaccination is one of the best ways to protect against potentially harmful diseases that can be very serious, may require hospitalization, or even be deadly. Almost all individuals who are vaccinated have no serious reactions.1
Nonetheless, in the 1980s, Congress became concerned that a small number of children who received immunizations had serious reactions to them, and it was not always possible to predict which children would have reactions, or what reactions they would have.2 Claimants alleging vaccinerelated injuries in civil litigation encountered a time-consuming, expensive, and often inadequate system.3 Moreover, increased litigation against vaccine manufacturers resulted in difficulties in their ability to secure affordable product liability insurance, 1 National Vaccine Injury Compensation Program, Health Resources & Servs. Admin., https
www.hrsa.gov/vaccine-compensation/index.html last reviewed Jan. 2020.
2 H.R. Rep. No. 99908, pt. 1, at 6 1986. Even though in rare instances individuals may have adverse reactions to vaccines, the Centers for Disease Control and Prevention CDC recommends that individuals be vaccinated against a wide range of illnesses and diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control &
Prevention, https www.cdc.gov/vaccines/vpd/
vaccines-age.html last reviewed Nov. 22, 2016.
3 H.R. Rep. No. 99908, at 6.

PO 00000

Frm 00007

Fmt 4700

Sfmt 4700

6249

stabilize vaccine prices and supply, and enter the market.4
Therefore, Congress enacted the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99660
42 U.S.C. 300aa1 et seq. Vaccine Act or the Act, which established the National Vaccine Injury Compensation Program VICP. The objectives of the VICP are to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines to be federally compensated. Petitions for compensation under the VICP are filed in the United States Court of Federal Claims Court, rather than the civil tort system, with a copy served on the Secretary, who is the Respondent. The U.S. Department of Justice DOJ
represents HHS in Court, and the Court, acting through judicial officers called Special Masters, makes the final decision as to eligibility for, and the type and amount of, compensation.
To gain entitlement to compensation under this Program, a petitioner must establish that a vaccine-related injury or death has occurred, either by proving that a vaccine actually caused or significantly aggravated an injury causation-in-fact or by demonstrating what is referred to as a Table injury.
That is, a petitioner may show that the vaccine recipient 1 received a vaccine covered under the Act; 2 suffered an injury of the type enumerated in the regulations at 42 CFR 100.3the Vaccine Injury Table Table corresponding to the vaccination in question; and 3 that the onset of such injury took place within the time period specified in the Table. If so, the injury is presumed to have been caused by the vaccine, and the petitioner is entitled to compensation assuming that other requirements are satisfied, unless the respondent affirmatively shows that the injury was caused by some factor unrelated to the vaccination see 42
U.S.C. 300aa11c1Ci, 300aa 13a1B, and 300aa14a.
42 U.S.C. 300aa14c and e permit the Secretary to revise the Table. The Table currently includes 17 vaccine categories, with 16 categories for specific vaccines, as well as the corresponding illnesses, disabilities, injuries, or conditions covered, and the requisite time period when the first symptom or manifestation of onset or of significant aggravation after the vaccine administration must begin to receive the Tables legal presumption of causation.
The final category of the Table, Item 4 See
E:FRFM21JAR1.SGM

id. at 46.

21JAR1