National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 1804-1805 [2014-00199]

Download as PDF 1804 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules training; and requirements for inspections, annual reviews, and renewal. Fees for training providers were also modified so that the annual renewal would not lead to a fee increase over the EPA program. During the public hearings before the Air Quality Council, concerns were raised that the DEQ RRP program would cause financial hardship on renovation firms and training providers that were already approved by EPA at the time of delegation approval and might have several years left before they were required to renew under the EPA program. In response, the proposed rules were amended to include transition language exempting EPAapproved firms and training providers from fees until the expiration of their EPA-approval. The Oklahoma RRP program will utilize the existing accreditation structure of inspections and close review to ensure a quality training system. The existing DEQ enforcement system will also apply to the RRP program, but for the RRP firms and their work practices, much of the enforcement will come through the DEQ complaint system. The complaint system uses a toll-free state wide number, strict timelines for response and investigation, and referral to the various DEQ divisions for expert followup. The DEQ complaint system is wellestablished and has proven effective in all programs, including the Oklahoma LBP activities program. The activities program provides a network of individuals and firms throughout the state that also self-monitor to assist in compliance. mstockstill on DSK4VPTVN1PROD with PROPOSALS IV. Federal Overfiling Section 404(b) of TSCA makes it unlawful for any person to violate, or fail or refuse to comply with, any requirement of an approved state program. Therefore, EPA reserves the right to exercise its enforcement authority under TSCA against a violation of, or a failure or refusal to comply with, any requirement of an authorized state program. 16:33 Jan 09, 2014 Jkt 232001 List of Subjects in 40 CFR 745 Environmental protection, Hazardous substances, Lead poisoning, Reporting and recordkeeping requirements. Dated: December 19, 2013. Ron Curry, Regional Administrator, Region 6. [FR Doc. 2014–00270 Filed 1–9–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 100 RIN 0906–AB00 National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table Office of the Secretary, HHS. Notice of public hearing. AGENCY: ACTION: This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ‘‘National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.’’ DATES: The public hearing will be held on January 13, 2014, from 10:30 a.m.– 12 p.m. (EDT). ADDRESSES: The public hearing will be held in Conference Room 10–65 in the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: Dr. Vito Caserta, Acting Director, Division of Vaccine Injury Compensation, at 855– 266–2427 or by email vcaserta@ hrsa.gov. SUMMARY: The National Childhood Vaccine Injury Act of 1986, Title III of Public Law 99–660, as amended (42 U.S.C. 300aa–10 et seq.), established the National Vaccine Injury Compensation Program (VICP) for persons found to be injured by vaccines. The Secretary has taken the necessary initial steps to propose to amend the Vaccine Injury Table to add intussusception as an injury associated with rotavirus vaccines. The NPRM was published in the Federal Register, July 24, 2013: 78 FR 44512. The public comment period closes January 21, 2014. A public hearing will be held during the 180-day public comment period. This hearing is to provide an open forum for the presentation of information and views concerning all SUPPLEMENTARY INFORMATION: V. Withdrawal of Authorization Pursuant to section 404(c) of TSCA, the EPA Administrator may withdraw authorization of a State or Indian tribal renovation, repair and painting program, and/or a lead-based paint prerenovation education program, after notice and opportunity for corrective action, if the program is not being administered or enforced in compliance with standards, regulations, and other requirements established under the authorization. The procedures U.S. EPA VerDate Mar<15>2010 will follow for the withdrawal of an authorization are found at 40 CFR 745.324(I). PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 aspects of the NPRM by interested persons. In preparing a final regulation, the Secretary will consider the administrative record of this hearing along with all other written comments received during the comment period specified in the NPRM. Individuals or representatives of interested organizations are invited to participate in the public hearing in accord with the schedule and procedures set forth below. The hearing will be held on January 13, 2014, beginning at 10:30 a.m. and ending at 12 p.m. (EDT) in Conference Room 10–65 in the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Upon entering the Parklawn Building, persons who wish to attend the hearing will be required to call Ms. Andrea Herzog at (301) 443–6634 to be escorted to Conference Room 10–65. The public can also join the meeting via audio conference call: Audio Conference Call: Dial 800–369– 3104 and provide the following information: Leader’s Name: Dr. Vito Caserta Password: HRSA The presiding officer representing the Secretary, HHS will be Dr. Vito Caserta, Acting Director, Division of Vaccine Injury Compensation, Healthcare Systems Bureau (HSB), Health Resources and Services Administration. Persons who wish to participate are requested to file a notice of participation with the Department of Health and Human Services (HHS) on or before January 9, 2014. The notice should be mailed to the Division of Vaccine Injury Compensation, HSB, Room 11C–26, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857 or emailed to aherzog@hrsa.gov. To ensure timely handling, any outer envelope or the subject line of an email should be clearly marked ‘‘VICP NPRM Hearing.’’ The notice of participation should contain the interested person’s name, address, email address, telephone number, any business or organizational affiliation of the person desiring to make a presentation, a brief summary of the presentation, and the approximate time requested for the presentation. Groups that have similar interests should consolidate their comments as part of one presentation. Time available for the hearing will be allocated among the persons who properly file notices of participation. If time permits, interested parties attending the hearing who did not submit notice of participation in advance will be allowed to make an oral presentation at the conclusion of the hearing. E:\FR\FM\10JAP1.SGM 10JAP1 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Proposed Rules Persons who find that there is insufficient time to submit the required information in writing may give oral notice of participation by calling Andrea Herzog, Division of Vaccine Injury Compensation, at (301) 443–6634, no later than January 9, 2014. After reviewing the notices of participation and accompanying information, HHS will schedule each appearance and notify each participant by mail, email, or telephone of the time allotted to the person(s) and the approximate time the person’s oral presentation is scheduled to begin. Written comments and transcripts of the hearing will be made available for public inspection as soon as they have been prepared, on weekdays (federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m. (EDT) at the Division of Vaccine Injury Compensation, Room 11C–26, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. the public comment period on our April 25, 2013, proposed rule to designate critical habitat for these species. We also announce the availability of a draft economic analysis (DEA) of the proposed designation of critical habitat for the Sierra Nevada yellow-legged frog, the northern DPS of the mountain yellow-legged frog, and the Yosemite toad and an amended required determinations section of the proposal. We are also announcing the location and time of a public hearing to receive public comments on the proposals, as well as the times and locations of two public meetings. We are reopening the comment periods to allow all interested parties an opportunity to comment simultaneously on the proposed rules, the associated DEA, and the amended required determinations section. Comments previously submitted need not be resubmitted, as they will be fully considered in preparation of the final rule. Dated: January 6, 2014. Kathleen Sebelius, Secretary. We will consider comments on the proposed rules published April 25, 2013 (78 FR 24472 and 78 FR 24516) received or postmarked on or before March 11, 2014. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES section, below) must be received by 11:59 p.m. Eastern Time on the closing date. Public Hearing: We will hold a public hearing on these proposed rules in Sacramento, California, on January 30, 2014, at 1:00 p.m. and again at 6:00 p.m. (see ADDRESSES). Public Meetings: We will hold two public meetings to provide information on these proposed rules in Bridgeport, California, on January 8, 2014, from 1:00 p.m. to 3:00 p.m. and in Fresno, California, on January 13, 2014, from 1:00 p.m. to 3:00 p.m. (see ADDRESSES). ADDRESSES: Document availability: You may obtain copies of the proposed rules and the associated documents of the draft economic analysis on the internet at https://www.regulations.gov at Docket No. FWS–R8–ES–2012–0100 and Docket No. FWS–R8–ES–2012–0074 or by mail from the Sacramento Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT). Written comments: You may submit written comments by one of the following methods: (1) Electronically: Go to the Federal eRulemaking Portal: https:// www.regulations.gov. Search for Docket No. FWS–R8–ES–2012–0100 (the docket number for the proposed listing rule) or FWS–R8–ES–2012–0074 (the docket DATES: [FR Doc. 2014–00199 Filed 1–9–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket Nos. FWS–R8–ES–2012–0100; FWS–R8–ES–2012–0074; 4500030113] RIN 1018–AZ21; RIN 1018–AY07 Endangered and Threatened Wildlife and Plants; Endangered Status for the Sierra Nevada Yellow-Legged Frog and the Northern Distinct Population Segment of the Mountain YellowLegged Frog, and Threatened Status for the Yosemite Toad and Designation of Critical Habitat Fish and Wildlife Service, Interior. ACTION: Proposed rules; reopening of the comment periods. AGENCY: We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period on our April 25, 2013, proposed rule to list the Sierra Nevada yellow-legged frog and the northern distinct population segment (DPS) of the mountain yellowlegged frog (populations that occur north of the Tehachapi Mountains) as endangered species, and the Yosemite toad as a threatened species under the Endangered Species Act of 1973, as amended (Act). We are also reopening mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:33 Jan 09, 2014 Jkt 232001 PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 1805 number for the proposed critical habitat rule). (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS–R8–ES–2012– 0100 (if commenting on the proposed listing rule) or FWS–R8–ES–2012–0074 (if commenting on the proposed critical habitat rule); Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, MS 2042–PDM; Arlington, VA 22203. We request that you send comments only by the methods described above. We will post all comments on https:// www.regulations.gov. This generally means that we will post any personal information you provide us (see the Public Comments section below for more information). Public informational sessions and public hearing: The public informational sessions and hearing will be held at Mono County Board of Supervisors Chambers in the Mono County Courthouse, State Highway 395 North, Bridgeport, CA 93517, and the Fresno County Board of Supervisors Chambers in the Hall of Records, Room 301, 2281 Tulare Street, Fresno, CA 93721. The hearing will be held at the Sacramento Horsemen’s Association, 3200 Longview Drive, Sacramento, CA 9582. People needing reasonable accommodations in order to attend and participate in the public hearing should contact Jennifer Norris, Field Supervisor, Sacramento Fish and Wildlife Office, as soon as possible (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Jennifer Norris, Field Supervisor, U.S. Fish and Wildlife Service, Sacramento Fish and Wildlife Office, 2800 Cottage Way Room W–2605, Sacramento CA 95825; by telephone 916–414–6600; or by facsimile 916–414–6712. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800–877–8339. SUPPLEMENTARY INFORMATION: Public Comments We will accept written comments and information during this reopened comment period on our proposed rule to list the Sierra Nevada yellow-legged frog, the northern DPS of the mountain yellow-legged frog as endangered species, and the Yosemite toad as a threatened species, that was published in the Federal Register on April 25, 2013 (78 FR 24472). We will consider information and recommendations from all interested parties. We are particularly interested in comments concerning: E:\FR\FM\10JAP1.SGM 10JAP1

Agencies

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Proposed Rules]
[Pages 1804-1805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB00


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table

AGENCY: Office of the Secretary, HHS.

ACTION: Notice of public hearing.

-----------------------------------------------------------------------

SUMMARY: This document announces a public hearing to receive 
information and views on the Notice of Proposed Rulemaking (NPRM) 
entitled ``National Vaccine Injury Compensation Program: Revisions to 
the Vaccine Injury Table.''

DATES: The public hearing will be held on January 13, 2014, from 10:30 
a.m.-12 p.m. (EDT).

ADDRESSES: The public hearing will be held in Conference Room 10-65 in 
the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: Dr. Vito Caserta, Acting Director, 
Division of Vaccine Injury Compensation, at 855-266-2427 or by email 
vcaserta@hrsa.gov.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986, Title III of Public Law 99-660, as amended (42 U.S.C. 300aa-10 et 
seq.), established the National Vaccine Injury Compensation Program 
(VICP) for persons found to be injured by vaccines. The Secretary has 
taken the necessary initial steps to propose to amend the Vaccine 
Injury Table to add intussusception as an injury associated with 
rotavirus vaccines.
    The NPRM was published in the Federal Register, July 24, 2013: 78 
FR 44512. The public comment period closes January 21, 2014.
    A public hearing will be held during the 180-day public comment 
period. This hearing is to provide an open forum for the presentation 
of information and views concerning all aspects of the NPRM by 
interested persons.
    In preparing a final regulation, the Secretary will consider the 
administrative record of this hearing along with all other written 
comments received during the comment period specified in the NPRM. 
Individuals or representatives of interested organizations are invited 
to participate in the public hearing in accord with the schedule and 
procedures set forth below.
    The hearing will be held on January 13, 2014, beginning at 10:30 
a.m. and ending at 12 p.m. (EDT) in Conference Room 10-65 in the 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Upon 
entering the Parklawn Building, persons who wish to attend the hearing 
will be required to call Ms. Andrea Herzog at (301) 443-6634 to be 
escorted to Conference Room 10-65.
    The public can also join the meeting via audio conference call:

Audio Conference Call: Dial 800-369-3104 and provide the following 
information:
    Leader's Name: Dr. Vito Caserta
    Password: HRSA

    The presiding officer representing the Secretary, HHS will be Dr. 
Vito Caserta, Acting Director, Division of Vaccine Injury Compensation, 
Healthcare Systems Bureau (HSB), Health Resources and Services 
Administration.
    Persons who wish to participate are requested to file a notice of 
participation with the Department of Health and Human Services (HHS) on 
or before January 9, 2014. The notice should be mailed to the Division 
of Vaccine Injury Compensation, HSB, Room 11C-26, Parklawn Building, 
5600 Fishers Lane, Rockville, Maryland 20857 or emailed to 
aherzog@hrsa.gov. To ensure timely handling, any outer envelope or the 
subject line of an email should be clearly marked ``VICP NPRM 
Hearing.'' The notice of participation should contain the interested 
person's name, address, email address, telephone number, any business 
or organizational affiliation of the person desiring to make a 
presentation, a brief summary of the presentation, and the approximate 
time requested for the presentation. Groups that have similar interests 
should consolidate their comments as part of one presentation. Time 
available for the hearing will be allocated among the persons who 
properly file notices of participation. If time permits, interested 
parties attending the hearing who did not submit notice of 
participation in advance will be allowed to make an oral presentation 
at the conclusion of the hearing.

[[Page 1805]]

    Persons who find that there is insufficient time to submit the 
required information in writing may give oral notice of participation 
by calling Andrea Herzog, Division of Vaccine Injury Compensation, at 
(301) 443-6634, no later than January 9, 2014.
    After reviewing the notices of participation and accompanying 
information, HHS will schedule each appearance and notify each 
participant by mail, email, or telephone of the time allotted to the 
person(s) and the approximate time the person's oral presentation is 
scheduled to begin.
    Written comments and transcripts of the hearing will be made 
available for public inspection as soon as they have been prepared, on 
weekdays (federal holidays excepted) between the hours of 8:30 a.m. and 
5 p.m. (EDT) at the Division of Vaccine Injury Compensation, Room 11C-
26, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

    Dated: January 6, 2014.
Kathleen Sebelius,
Secretary.
[FR Doc. 2014-00199 Filed 1-9-14; 8:45 am]
BILLING CODE 4165-15-P
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