83 FR 32301 - Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 134 (July 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 134 (July 12, 2018)
| Page Range | 32301-32301 | |
| FR Document | 2018-14943 |
[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)] [Notices] [Page 32301] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14943] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2642] Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal AGENCY: Food and Drug Administration, HHS. ACTION: Notice; renewal of advisory committee. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the renewal of the Science Advisory Board (the Board) to the National Center for Toxicological Research (NCTR) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Board to the NCTR for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 2, 2020. DATES: Authority for the Board to the NCTR expired on June 2, 2018; however, the Commissioner formally determined that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Donna L. Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892, [email protected]. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Board to the NCTR. The Board is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Board to the NCTR advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Board advises the NCTR Director in establishing, implementing, and evaluating the research programs that assist the Commissioner in fulfilling regulatory responsibilities. The Board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent. The Board shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of toxicological research. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this Board serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm. Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14943 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32301
indicate acceptability of the hearing date that DEPARTMENT OF HEALTH AND designee from among authorities
has been scheduled and provide names of the HUMAN SERVICES knowledgeable in the fields of
individuals who will represent the State at toxicological research. Members will be
the hearing. If the hearing date is not Food and Drug Administration invited to serve for overlapping terms of
acceptable, Mr. Cohen can set another date up to 4 years. Almost all non-Federal
mutually agreeable to the parties. The [Docket No. FDA–2018–N–2642]
members of this Board serve as Special
hearing will be governed by the procedures Government Employees. The core of
prescribed by federal regulations at 42 CFR
Advisory Committee; Science Advisory
Board to the National Center for voting members may include one
Part 430.
Toxicological Research; Renewal technically qualified member, selected
This SPA requested CMS approval to add
by the Commissioner or designee, who
coverage and reimbursement of services AGENCY: Food and Drug Administration,
provided by Dental Health Aide Therapists
is identified with consumer interests
HHS. and is recommended by either a
(DHATs) under the Other Licensed
Practitioner (OLP) benefit. Specifically, SPA ACTION:Notice; renewal of advisory consortium of consumer-oriented
17–0027 proposed the coverage and committee. organizations or other interested
reimbursement of services provided by persons.
SUMMARY: The Food and Drug Further information regarding the
DHATs only when furnished in a practice
setting within the boundaries of a tribal
Administration (FDA) is announcing the most recent charter and other
reservation and only when operated by an renewal of the Science Advisory Board information can be found at https://
Indian health program, and proposed to make (the Board) to the National Center for www.fda.gov/AdvisoryCommittees/
coverage of DHAT services available only to Toxicological Research (NCTR) by the CommitteesMeetingMaterials/
members of a federally recognized tribe or Commissioner of Food and Drugs (the ToxicologicalResearch/ucm148166.htm
those otherwise eligible for services under Commissioner). The Commissioner has or by contacting the Designated Federal
Indian Health Service criteria. Washington determined that it is in the public Officer (see FOR FURTHER INFORMATION
would, therefore, not permit Medicaid interest to renew the Board to the NCTR CONTACT). In light of the fact that no
beneficiaries to receive Medicaid coverage for for an additional 2 years beyond the change has been made to the committee
DHAT services if they are not members of a charter expiration date. The new charter name or description of duties, no
federally recognized tribe or otherwise will be in effect until June 2, 2020. amendment will be made to 21 CFR
eligible for services under Indian Health DATES: Authority for the Board to the 14.100.
Service criteria. NCTR expired on June 2, 2018; This document is issued under the
The issues to be considered at the hearing Federal Advisory Committee Act (5
however, the Commissioner formally
are whether Washington SPA 17–0027 is U.S.C. app.). For general information
determined that renewal is in the public
inconsistent with the requirements of: related to FDA advisory committees,
• Section 1902(a)(23) of the Social Security
interest.
please check https://www.fda.gov/
Act (the Act) because it would restrict access FOR FURTHER INFORMATION CONTACT:
AdvisoryCommittees/default.htm.
to services provided by a DHAT to a limited Donna L. Mendrick, National Center for
group of beneficiaries, and it would also Toxicological Research, Food and Drug Dated: July 9, 2018.
prevent beneficiaries from receiving DHAT Administration, 10903 New Hampshire Leslie Kux,
services from similarly qualified dental Ave., Bldg. 32, Rm. 2208, Silver Spring, Associate Commissioner for Policy.
services providers that provide services MD 20993–0002, 301–796–8892, [FR Doc. 2018–14943 Filed 7–11–18; 8:45 am]
outside the boundaries of a tribal reservation donna.mendrick@fda.hhs.gov. BILLING CODE 4164–01–P
or that are not Indian health programs. SUPPLEMENTARY INFORMATION: Pursuant
• Section 1902(a)(10)(A) of the Act because
to 41 CFR 102–3.65 and approval by the
it was unclear whether DHATs must be DEPARTMENT OF HEALTH AND
Department of Health and Human
supervised by a licensed professional HUMAN SERVICES
consistent with the requirements of the OLP
Services pursuant to 45 CFR part 11 and
benefit, and because CMS was therefore by the General Services Administration,
Food and Drug Administration
unable to determine whether DHAT services FDA is announcing the renewal of the
are ‘‘medical assistance’’ consistent with Board to the NCTR. The Board is a [Docket No. FDA–2018–N–2565]
1902(a)(10)(A) and 1905 of the Act. discretionary Federal advisory
In the event that CMS and the State come committee established to provide advice Advisory Committee;
to agreement on resolution of the issues to the Commissioner. The Board to the Psychopharmacologic Drugs Advisory
which formed the basis for disapproval, this NCTR advises the Commissioner or Committee; Renewal
SPA may be moved to approval prior to the designee in discharging responsibilities AGENCY: Food and Drug Administration,
scheduled hearing. as they relate to helping to ensure safe HHS.
Sincerely, and effective drugs for human use and, ACTION:Notice; renewal of advisory
as required, any other product for which committee.
Seema Verma FDA has regulatory responsibility. The
Administrator Board advises the NCTR Director in SUMMARY: The Food and Drug
Section 1116 of the Social Security Act (42 establishing, implementing, and Administration (FDA) is announcing the
U.S.C. section 1316; 42 CFR section 430.18) evaluating the research programs that renewal of the Psychopharmacologic
(Catalog of Federal Domestic Assistance assist the Commissioner in fulfilling Drugs Advisory Committee by the
program No. 13.714. Medicaid Assistance regulatory responsibilities. The Board Commissioner of Food and Drugs (the
Program.) provides an extra-agency review in Commissioner). The Commissioner has
amozie on DSK3GDR082PROD with NOTICES1
ensuring that the research programs at determined that it is in the public
Dated: July 6, 2018.
NCTR are scientifically sound and interest to renew the
Seema Verma, pertinent. Psychopharmacologic Drugs Advisory
Administrator, Centers for Medicare & The Board shall consist of a core of Committee for an additional 2 years
Medicaid Services. nine voting members including the beyond the charter expiration date. The
[FR Doc. 2018–14876 Filed 7–6–18; 4:15 pm] Chair. Members and the Chair are new charter will be in effect until June
BILLING CODE 4120–01–P selected by the Commissioner or 4, 2020.
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Document Created: 2018-11-06 10:22:14
Document Modified: 2018-11-06 10:22:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; renewal of advisory committee. | |
| Dates | Authority for the Board to the NCTR expired on June 2, 2018; however, the Commissioner formally determined that renewal is in the public interest. | |
| Contact | Donna L. Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892, [email protected] | |
| FR Citation | 83 FR 32301 |
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