National Toxicology Program (Ntp); Office of Chemical Nomination and Selection; Announcement of and Request for Public Comment on Toxicological Study Nominations to the NTP, 18341-18344 [E6-5217]

Download as PDF Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices staff with a better understanding of the biologics industry and its operations. CBER initiated its RSVP in 2005. This program is intended to improve CBER’s understanding of current practices, regulatory impacts and needs, and communication between CBER staff and industry. CBER is reannouncing the invitation for participation in its RSVP, and is requesting those firms who previously applied and are still interested in participating to reaffirm their interest, as well as encouraging new interested parties to apply. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. RSVP ACTION: A. Regulatory Site Visits Food and Drug Administration [Docket No. 2000D–1341] Draft Guidance for Industry: Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on July 11, 2001. DATES: April 11, 2006. FOR FURTHER INFORMATION CONTACT: Pamela Pope, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of July 11, 2001 (66 FR 36287), FDA announced the availability of a draft guidance entitled ‘‘Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier.’’ This draft guidance described a pilot program in which biologics manufacturers could selfcertify conformance to licensing criteria prescribed by FDA. This action was intended to reduce unnecessary burdens for industry without diminishing public health protection. The draft guidance is being withdrawn because FDA has determined that there is a lack of industry interest in pursuing the pilot licensing program outlined in the draft guidance. SUMMARY: In this program, over a period of time to be agreed upon with the facility, small groups of CBER staff may observe operations of biologics establishments, including, for example, blood and tissue establishments. The visits may include packaging facilities, quality control and pathology/toxicology laboratories, and regulatory affairs operations. These visits, or any part of the program, are not intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but are meant to improve mutual understanding and to provide an avenue for open dialog between the biologics industry and CBER. B. Site Selection All travel expenses associated with the site visits will be the responsibility of CBER. Therefore, selection of potential facilities will be based on the coordination of CBER’s priorities for staff training as well as the limited available resources for this program. In addition to logistical and other resource factors to consider, a key element of site selection is a successful compliance record with CBER or another agency for which we have a memorandum of understanding. Dated: March 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–5221 Filed 4–10–06; 8:45 am] BILLING CODE 4160–01–S Dated: March 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–5220 Filed 4–10–06; 8:45 am] BILLING CODE 4160–01–S wwhite on PROD1PC61 with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Aug<31>2005 19:37 Apr 10, 2006 Jkt 208001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 18341 amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, NEI P30/R24 Review Meeting. Date: April 20, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Sofitel Lafayette Square, 806 15th Street, NW., Washington, DC 20005. Contact Person: Samuel Rawlings, PhD, Chief, Scientific Review Branch, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, MSC 9300, Bethesda, MD 20892–9300, 301–451–2020. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: April 3, 2006. David Clary, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–3415 Filed 4–10–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (Ntp); Office of Chemical Nomination and Selection; Announcement of and Request for Public Comment on Toxicological Study Nominations to the NTP National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health. ACTION: Notice; request for comments and additional information. AGENCY: SUMMARY: The NTP continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice (1) provides brief background information E:\FR\FM\11APN1.SGM 11APN1 18342 Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices and study recommendations regarding 10 nominations for study by the NTP (Table 1), (2) solicits public comment on the nominations and study recommendations, and (3) requests the submission of additional relevant information for consideration by the NTP in its continued review of these nominations. An electronic copy of this announcement, supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site (https://ntp.niehs.nih.gov/; select ‘‘Nominations to the Testing Program’’). DATES: Comments or information should be submitted by May 10, 2006. ADDRESSES: Correspondence should be addressed to Dr. Scott A. Masten, Director, Office of Chemical Nomination and Selection, NIEHS/NTP, 111 T.W. Alexander Drive, P. O. Box 12233, Research Triangle Park, North Carolina 27709; telephone: 919–541–5710; FAX: 919–541–3647; e-mail: masten@niehs.nih.gov. SUPPLEMENTARY INFORMATION: wwhite on PROD1PC61 with NOTICES Background Information The NTP actively seeks to identify and select for study chemicals and other substances for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal open nomination and selection process. Nominations can be submitted to the NTP at https://ntp.niehs.nih.gov/ select ‘‘Nominations to the Testing Program’’ or by contacting Dr. Scott Masten (see ADDRESSES above). Substances considered appropriate for study generally fall into two broad yet overlapping categories: (1) Substances judged to have high concern as possible public health hazards based on the extent of human exposure and/or suspicion of toxicity and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g. by facilitating cross-species extrapolation or for evaluating doseresponse relationships. Nominations are also solicited for studies that permit the testing of hypotheses to enhance the predictive ability of future NTP studies, address mechanisms of toxicity, or fill significant gaps in the knowledge of the toxicity of classes of chemical, biological, or physical agents. Study nominations may entail the evaluation of a variety of health-related effects including, but not limited to, reproductive and developmental toxicity, genetic toxicity, immunotoxicity, neurotoxicity, VerDate Aug<31>2005 19:37 Apr 10, 2006 Jkt 208001 metabolism and disposition, and carcinogenicity in appropriate experimental models. In reviewing and selecting nominations for study, the NTP also considers legislative mandates that require responsible private sector organizations to evaluate their products for health and environmental effects. The possible human health consequences of anticipated or known human exposure, however, remain the over-riding factor in the NTP’s decision to study a particular substance. Nominations undergo a multi-step, formal process of review. Briefly, during the entire nomination review and selection process, the NTP works with staff at other federal agencies and interested parties to supplement information about nominated substances and to ensure that regulatory and public health needs are addressed. The nomination review and selection process is accomplished through the participation of representatives from the NIEHS, other federal agencies represented on the Interagency Committee for Chemical Evaluation and Coordination (ICCEC), the NTP Board of Scientific Counselors (BSC)—an external scientific advisory body, the NTP Executive Committee—the NTP federal interagency policy body, and the public. Preliminary study recommendations for each nomination are developed and refined by the nominator, NTP staff, and the ICCEC. Preliminary study recommendation for the nominations may be refined as the formal review process continues. NTP also considers recommendations from the BSC and the NTP Executive Committee, public comments received on the nominations, and other available information in selecting candidate substances for study. The NTP initiates appropriate toxicology and carcinogenicity studies as time and resources permit. The nomination review and selection process is described in further detail on the NTP Web site (https:// ntp.niehs.nih.gov/; select ‘‘Nominations to the Testing Program’’). Request for Comments and Additional Information The NTP invites interested parties to submit written comments or supplementary information on the nominated substances and study recommendations that appear in Table 1. The NTP welcomes toxicology and carcinogenesis study information from completed, ongoing, or anticipated studies, as well as information on current U.S. production levels, use or consumption patterns, human exposure, environmental occurrence, or public health concerns for any of the PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 nominated substances. The NTP is interested in identifying appropriate animal and non-animal experimental models for mechanistic-based research, including genetically modified rodents and higher-throughput in vitro test methods, and as such, solicits comments regarding the use of specific in vivo and in vitro experimental approaches to address questions relevant to the nominated substances and issues under consideration. The BSC will discuss the nominations listed in Table 1 at a public meeting on June 13, 2006. A separate Federal Register notice will be published in the future about this meeting. Comments or additional information may be submitted at any time; however, to ensure adequate time for consideration prior to the June 13, 2006 BSC meeting, comments should be submitted by May 10, 2006. The NTP will not respond to submitted comments; however, all information received will be become part of the official record that the NTP considers in its ongoing review of these nominations. Persons submitting comments should include their name, affiliation, mailing address, phone, fax, e-mail address, and sponsoring organization (if any) with the submission. Written submissions will be made publicly available electronically on the NTP website as they are received (https://ntp.niehs.nih.gov/ select ‘‘Nominations to the Testing Program’’). Background Information on the NTP Office of Chemical Nomination and Selection The NTP Office of Chemical Nomination and Selection (OCNS) manages the solicitation, receipt, and review of NTP toxicology study nominations. The OCNS conducts an initial review of each study nomination received to determine whether the substance or issue has been adequately studied or has been previously considered by the NTP. For nominations not eliminated from consideration or deferred at this stage, the OCNS initiates a formal review process, as described above. The OCNS also ensures adequate background information is available to support the review for each nomination and corresponds with interested parties regarding the status of NTP study nominations. For further information on the OCNS visit the NTP Web site (https:// ntp.niehs.nih.gov select ‘‘Nominations to the Testing Program’’) or contact Dr. Masten (see ADDRESSES above). Dated: March 28, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. E:\FR\FM\11APN1.SGM 11APN1 Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices 18343 TABLE 1.—STUDY RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES Substance [CAS No.] Nominated by 1 Nomination Rationale Study Recommendations 2 Arbutin 497–76–7] ......................... NIEHS ........................................... Consumer exposure through food, cosmetics, and dietary supplements; lack of adequate toxicological data; suspicion of toxicity based on chemical structure. tert-Butylacrylamide [107–58–4] .... NCI ................................................ High production volume (HPV); potential worker and consumer exposures; lack of adequate toxicological data; suspicion of toxicity based on chemical structure. —In vitro and in vivo metabolism and disposition studies. —In vitro and in vivo genotoxicity studies. —Emphasis on understanding gastrointestinal metabolism and disposition, identifying experimental animal model representative of humans, and development of appropriate biomarkers. —Metabolism and disposition studies. —Subchronic toxicity studies. —Mammalian genotoxicity studies. —Coordinate studies with voluntary data development activities of the Extended HPV (EHPV) Program. Ceric oxide [1306–38–3] ................ NIEHS ........................................... Diazonaphthoquinone derivatives Sodium 1,2-naphthoquinone-2diazide-5-sulfonate [2657–00–3] 2,3,4-Trihydroxybenzophenone tris(1,2-naphthoquinonediazide5-sulfonate) [5610–94–6] 2,3,4Trihydroxybenzophenone 1,2naphthoquinonediazide-5sulfonate [68510–93–0]. 3-Dimethylaminopropyl methacrylamide [5205–93–6]. NIEHS ........................................... Widespread industrial use and potential for increasing exposure; demonstrated pulmonary toxicity; lack of toxicity data for nanoscale form. —Toxicological characterization including chemical disposition and toxicokinetics. —Comparative inhalation toxicity studies of microscale and nanoscale forms. —Dermal penetration studies. Moderate production volume; potential worker exposures from production and use of photoresists; lack of adequate toxicological data. High production volume (HPV); potential worker and consumer exposures; lack of adequate toxicological data; demonstrated toxicity in short-term studies. Flame retardants ............................ Antimony trioxide [1309–64–4] Decabromodiphenyl oxide [1163–19–5]. Consumer Product Safety Commission Staff. Anticipated increased use in upholstered furniture and bedding and potential consumer exposures from these uses; insufficient toxicity data to assess potential health risks. Tris (chloropropyl) phosphate, mixture of four isomers [13674–84– 5; 76025–08–6; 76649–15–5; 6145–73–9]. wwhite on PROD1PC61 with NOTICES NCI ................................................ ....................................................... ....................................................... Phosphonic acid, (3((hydroxymethyl) amino)-3oxopropyl)-, dimethyl ester [20120–33–6]. ....................................................... ....................................................... VerDate Aug<31>2005 19:37 Apr 10, 2006 Jkt 208001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\11APN1.SGM —In vitro toxicity studies evaluating genotoxicity, immunotoxicity and phototoxicity. —Dermal penetration studies. —Metabolism and disposition studies. —Genotoxicity studies. —Subchronic toxicity studies. —Coordinate studies with voluntary data development activities of the Extended HPV (EHPV) Program. See specific chemicals below: —Chronic toxicity studies (oral route). —Consider studies of nanoscale form if used in or released during flame retardant applications. —Developmental neurotoxicity studies. —Studies only to be performed if adequate private sector study not identified or planned. —Subchronic and chronic toxicity studies (oral route). —Studies to focus on commercial mixture or major isomers present in commercially used mixtures. —Subchronic and chronic toxicity studies (oral route). —Dermal absorption studies. 11APN1 18344 Federal Register / Vol. 71, No. 69 / Tuesday, April 11, 2006 / Notices TABLE 1.—STUDY RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES— Continued Nominated by 1 Nomination Rationale Study Recommendations 2 phosphine ....................................................... ....................................................... Aromatic phosphates tertButylphenyl diphenyl phosphate [56803–37–3] 2-Ethylhexyl diphenyl phosphate [1241–94–7] Isodecyl diphenyl phosphate [29761–21–5] Phenol, isopropylated, phosphate (3:1) [68937–41–7] Tricresyl phosphate [1330–78–5] Triphenyl phosphate [115–86–6]. ....................................................... ....................................................... Gypsum, natural and forms [13397–24–5]. Mount Sinai-Irving J. Selikoff Center for Occupational and Environmental Medicine Operative Plasterers’ and Cement Masons’ International Association of the United States and Canada. Widespread worker exposures in numerous occupations and to the general population after destruction of the World Trade Centers in 2001; limited toxicity data to assess potential health risks. N-methyl-3-oxobutanamide [20306–75–6]. NCI ................................................ High production volume; potential worker and environmental exposures; lack of adequate toxicological data. Phenoxyethyl acrylate [48145–04– 6]. NCI ................................................ Trifluoromethylbenzene [98–08–8] NCI ................................................ High production volume; potential worker and consumer exposures; lack of adequate toxicological data. High production volume and potential for increased use; potential worker exposures; lack of adequate toxicological data; demonstrated toxicity in shortterm studies. —Subchronic and chronic toxicity studies (oral route). —Dermal absorption studies. For one or more representative aromatic phosphates: —Subchronic and chronic toxicity studies (oral route). —Neurotoxicity and/or developmental neurotoxicity studies. —Coordinate with the U.S. Environmental Protection Agency to pursue additional testing by manufacturers. —Short-term pulmonary toxicity studies. —Comparative studies of intratracheal versus inhalation routes of administration. —Studies are of relatively low priority given low suspicion of toxicity. —In vitro and in vivo genotoxicity studies. —Include structurally-related diketene compounds and Nphenyl derivatives. —Defer pending review of voluntary data submission through the Extended HPV (EHPV) Program. Defer pending review of 1) production data through the 2006 Toxic Substances Control Act (TSCA) Inventory Update Rule, and 2) Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) program output. Substance [CAS No.] Tris (hydroxymethyl) oxide [1067–12–5]. synthetic 1 National Institute of Environmental Health Sciences (NIEHS); National Cancer Institute (NCI) term ‘‘toxicological characterization’’ in this table includes studies for genotoxicity, subchronic toxicity, and chronic toxicity/carcinogenicity as determined to be appropriate during the conceptualization and design of a research program to address toxicological data needs. Other types of studies (e.g., metabolism and disposition, immunotoxicity, and reproductive and developmental toxicity) may be conducted as part of a complete toxicological characterization; however, these types of studies are not listed unless they are specifically recommended. 2 The [FR Doc. E6–5217 Filed 4–10–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–4889–N–07] Change of Effective Date of 2004 Amendatory Notice for Designation of Difficult Development Areas Under Section 42 of the Internal Revenue Code of 1986 Office of the Assistant Secretary for Policy Development and Research, HUD. ACTION: Notice. wwhite on PROD1PC61 with NOTICES AGENCY: SUMMARY: This notice changes the extended effective date language VerDate Aug<31>2005 19:37 Apr 10, 2006 Jkt 208001 applicable to 2003 Difficult Development Areas that were not so designated in 2004 in HUD’s November 2, 2004, notice to include the date of December 17, 2004, to allow its applicability to projects affected by a misinterpretation of the November 2, 2004, notice on the part of a LowIncome Housing Tax Credit-allocating agency. FOR FURTHER INFORMATION CONTACT: With questions related narrowly to the issue of the effective dates in this notice, Kurt G. Usowski, Associate Deputy Assistant Secretary for Economic Affairs, Office of Policy Development and Research, 451 Seventh Street, SW., Washington, DC 20410–6000, telephone (202) 708–2770, or e-mail Kurt_G._Usowski@hud.gov. A text PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 telephone is available for persons with hearing or speech impairments at (202) 708–9300. (These are not toll-free telephone numbers.) Copies Available Electronically: This notice is available electronically on the Internet (World Wide Web) at https:// www.huduser.org/datasets/qct.html. On December 19, 2003 (68 FR 7092), HUD published in the Federal Register the notice designating Difficult Development Areas (DDAs) and Qualified Census Tracts (QCTs) for calendar year 2004 (the 2004 notice). The 2004 notice provided that the lists of Difficult Development Areas are effective if the credits are allocated after December 31, 2003; and, in the case of a building described in section SUPPLEMENTARY INFORMATION: E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 71, Number 69 (Tuesday, April 11, 2006)]
[Notices]
[Pages 18341-18344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5217]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Toxicology Program (Ntp); Office of Chemical Nomination
and Selection; Announcement of and Request for Public Comment on
Toxicological Study Nominations to the NTP

AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health.

ACTION: Notice; request for comments and additional information.

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

SUMMARY: The NTP continuously solicits and accepts nominations for
toxicological studies to be undertaken by the program. Nominations of
substances of potential human health concern are received from federal
agencies, the public, and other interested parties. These nominations
are subject to several levels of review before selections for testing
are made and toxicological studies are designed and implemented. This
notice (1) provides brief background information

[[Page 18342]]

and study recommendations regarding 10 nominations for study by the NTP
(Table 1), (2) solicits public comment on the nominations and study
recommendations, and (3) requests the submission of additional relevant
information for consideration by the NTP in its continued review of
these nominations. An electronic copy of this announcement, supporting
documents for each nomination, and further information on the NTP and
the NTP Study Nomination and Review Process can be accessed through the
NTP Web site (https://ntp.niehs.nih.gov/; select ``Nominations to the
Testing Program'').

DATES: Comments or information should be submitted by May 10, 2006.

ADDRESSES: Correspondence should be addressed to Dr. Scott A. Masten,
Director, Office of Chemical Nomination and Selection, NIEHS/NTP, 111
T.W. Alexander Drive, P. O. Box 12233, Research Triangle Park, North
Carolina 27709; telephone: 919-541-5710; FAX: 919-541-3647; e-mail:
masten@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Background Information

The NTP actively seeks to identify and select for study chemicals
and other substances for which sufficient information is not available
to adequately evaluate potential human health hazards. The NTP
accomplishes this goal through a formal open nomination and selection
process. Nominations can be submitted to the NTP at https://
ntp.niehs.nih.gov/ select ``Nominations to the Testing Program'' or by
contacting Dr. Scott Masten (see ADDRESSES above). Substances
considered appropriate for study generally fall into two broad yet
overlapping categories: (1) Substances judged to have high concern as
possible public health hazards based on the extent of human exposure
and/or suspicion of toxicity and (2) substances for which toxicological
data gaps exist and additional studies would aid in assessing potential
human health risks, e.g. by facilitating cross-species extrapolation or
for evaluating dose-response relationships. Nominations are also
solicited for studies that permit the testing of hypotheses to enhance
the predictive ability of future NTP studies, address mechanisms of
toxicity, or fill significant gaps in the knowledge of the toxicity of
classes of chemical, biological, or physical agents.
Study nominations may entail the evaluation of a variety of health-
related effects including, but not limited to, reproductive and
developmental toxicity, genetic toxicity, immunotoxicity,
neurotoxicity, metabolism and disposition, and carcinogenicity in
appropriate experimental models. In reviewing and selecting nominations
for study, the NTP also considers legislative mandates that require
responsible private sector organizations to evaluate their products for
health and environmental effects. The possible human health
consequences of anticipated or known human exposure, however, remain
the over-riding factor in the NTP's decision to study a particular
substance.
Nominations undergo a multi-step, formal process of review.
Briefly, during the entire nomination review and selection process, the
NTP works with staff at other federal agencies and interested parties
to supplement information about nominated substances and to ensure that
regulatory and public health needs are addressed. The nomination review
and selection process is accomplished through the participation of
representatives from the NIEHS, other federal agencies represented on
the Interagency Committee for Chemical Evaluation and Coordination
(ICCEC), the NTP Board of Scientific Counselors (BSC)--an external
scientific advisory body, the NTP Executive Committee--the NTP federal
interagency policy body, and the public. Preliminary study
recommendations for each nomination are developed and refined by the
nominator, NTP staff, and the ICCEC. Preliminary study recommendation
for the nominations may be refined as the formal review process
continues. NTP also considers recommendations from the BSC and the NTP
Executive Committee, public comments received on the nominations, and
other available information in selecting candidate substances for
study. The NTP initiates appropriate toxicology and carcinogenicity
studies as time and resources permit.
The nomination review and selection process is described in further
detail on the NTP Web site (https://ntp.niehs.nih.gov/; select
``Nominations to the Testing Program'').

Request for Comments and Additional Information

The NTP invites interested parties to submit written comments or
supplementary information on the nominated substances and study
recommendations that appear in Table 1. The NTP welcomes toxicology and
carcinogenesis study information from completed, ongoing, or
anticipated studies, as well as information on current U.S. production
levels, use or consumption patterns, human exposure, environmental
occurrence, or public health concerns for any of the nominated
substances. The NTP is interested in identifying appropriate animal and
non-animal experimental models for mechanistic-based research,
including genetically modified rodents and higher-throughput in vitro
test methods, and as such, solicits comments regarding the use of
specific in vivo and in vitro experimental approaches to address
questions relevant to the nominated substances and issues under
consideration. The BSC will discuss the nominations listed in Table 1
at a public meeting on June 13, 2006. A separate Federal Register
notice will be published in the future about this meeting. Comments or
additional information may be submitted at any time; however, to ensure
adequate time for consideration prior to the June 13, 2006 BSC meeting,
comments should be submitted by May 10, 2006. The NTP will not respond
to submitted comments; however, all information received will be become
part of the official record that the NTP considers in its ongoing
review of these nominations. Persons submitting comments should include
their name, affiliation, mailing address, phone, fax, e-mail address,
and sponsoring organization (if any) with the submission. Written
submissions will be made publicly available electronically on the NTP
website as they are received (https://ntp.niehs.nih.gov/ select
``Nominations to the Testing Program'').

Background Information on the NTP Office of Chemical Nomination and
Selection

The NTP Office of Chemical Nomination and Selection (OCNS) manages
the solicitation, receipt, and review of NTP toxicology study
nominations. The OCNS conducts an initial review of each study
nomination received to determine whether the substance or issue has
been adequately studied or has been previously considered by the NTP.
For nominations not eliminated from consideration or deferred at this
stage, the OCNS initiates a formal review process, as described above.
The OCNS also ensures adequate background information is available to
support the review for each nomination and corresponds with interested
parties regarding the status of NTP study nominations. For further
information on the OCNS visit the NTP Web site (https://
ntp.niehs.nih.gov select ``Nominations to the Testing Program'') or
contact Dr. Masten (see ADDRESSES above).

Dated: March 28, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.

[[Page 18343]]

Table 1.--Study Recommendations for Substances Nominated to the NTP for Toxicological Studies
----------------------------------------------------------------------------------------------------------------
Study Recommendations
Substance [CAS No.] Nominated by \1\ Nomination Rationale \2\
----------------------------------------------------------------------------------------------------------------
Arbutin 497-76-7].................... NIEHS.................. Consumer exposure --In vitro and in vivo
through food, metabolism and
cosmetics, and dietary disposition studies.
supplements; lack of --In vitro and in vivo
adequate toxicological genotoxicity studies.
data; suspicion of --Emphasis on
toxicity based on understanding
chemical structure. gastrointestinal
metabolism and
disposition,
identifying
experimental animal
model representative
of humans, and
development of
appropriate
biomarkers.
tert-Butylacrylamide [107-58-4]...... NCI.................... High production volume --Metabolism and
(HPV); potential disposition studies.
worker and consumer --Subchronic toxicity
exposures; lack of studies.
adequate toxicological --Mammalian
data; suspicion of genotoxicity studies.
toxicity based on --Coordinate studies
chemical structure. with voluntary data
development activities
of the Extended HPV
(EHPV) Program.
Ceric oxide [1306-38-3].............. NIEHS.................. Widespread industrial
use and potential for
increasing exposure;
demonstrated pulmonary
toxicity; lack of
toxicity data for
nanoscale form.
--Toxicological
characterization
including chemical
disposition and
toxicokinetics.
--Comparative
inhalation toxicity
studies of microscale
and nanoscale forms.
--Dermal penetration
studies.
Diazonaphthoquinone derivatives NIEHS.................. Moderate production --In vitro toxicity
Sodium 1,2-naphthoquinone-2-diazide- volume; potential studies evaluating
5-sulfonate [2657-00-3] 2,3,4- worker exposures from genotoxicity,
Trihydroxybenzophenone tris(1,2- production and use of immunotoxicity and
naphthoquinonediazide-5-sulfonate) photoresists; lack of phototoxicity.
[5610-94-6] 2,3,4- adequate toxicological --Dermal penetration
Trihydroxybenzophenone 1,2- data. studies.
naphthoquinonediazide-5-sulfonate
[68510-93-0].
3-Dimethylaminopropyl methacrylamide NCI.................... High production volume --Metabolism and
[5205-93-6]. (HPV); potential disposition studies.
worker and consumer --Genotoxicity studies.
exposures; lack of --Subchronic toxicity
adequate toxicological studies.
data; demonstrated --Coordinate studies
toxicity in short-term with voluntary data
studies. development activities
of the Extended HPV
(EHPV) Program.
Flame retardants..................... Consumer Product Safety Anticipated increased See specific chemicals
Antimony trioxide [1309-64-4]........ Commission Staff. use in upholstered below:
Decabromodiphenyl oxide [1163-19-5].. furniture and bedding --Chronic toxicity
and potential consumer studies (oral route).
exposures from these --Consider studies of
uses; insufficient nanoscale form if used
toxicity data to in or released during
assess potential flame retardant
health risks. applications.
--Developmental
neurotoxicity studies.
--Studies only to be
performed if adequate
private sector study
not identified or
planned.
Tris (chloropropyl) phosphate, ....................... ....................... --Subchronic and
mixture of four isomers [13674-84-5; chronic toxicity
76025-08-6; 76649-15-5; 6145-73-9]. studies (oral
route).
--Studies to focus on
commercial mixture or
major isomers present
in commercially used
mixtures.
Phosphonic acid, (3-((hydroxymethyl) ....................... ....................... --Subchronic and
amino)-3-oxopropyl)-, dimethyl ester chronic toxicity
[20120-33-6]. studies (oral
route).
--Dermal absorption
studies.

[[Page 18344]]

Tris (hydroxymethyl) phosphine oxide ....................... ....................... --Subchronic and
[1067-12-5]. chronic toxicity
studies (oral
route).
--Dermal absorption
studies.
Aromatic phosphates tert-Butylphenyl ....................... ....................... For one or more
diphenyl phosphate [56803-37-3] 2- representative
Ethylhexyl diphenyl phosphate [1241- aromatic phosphates:
94-7] Isodecyl diphenyl phosphate --Subchronic and
[29761-21-5] Phenol, isopropylated, chronic toxicity
phosphate (3:1) [68937-41-7] studies (oral route).
Tricresyl phosphate [1330-78-5] --Neurotoxicity and/or
Triphenyl phosphate [115-86-6]. developmental
neurotoxicity studies.
--Coordinate with the
U.S. Environmental
Protection Agency to
pursue additional
testing by
manufacturers.
Gypsum, natural and synthetic forms Mount Sinai-Irving J. Widespread worker --Short-term
[13397-24-5]. Selikoff Center for exposures in numerous pulmonary toxicity
Occupational and occupations and to the studies.
Environmental Medicine general population --Comparative studies
Operative Plasterers' after destruction of of intratracheal
and Cement Masons' the World Trade versus inhalation
International Centers in 2001; routes of
Association of the limited toxicity data administration.
United States and to assess potential --Studies are of
Canada. health risks. relatively low
priority given low
suspicion of toxicity.
N-methyl-3-oxobutanamide [20306-75-6] NCI.................... High production volume; --In vitro and in vivo
potential worker and genotoxicity studies.
environmental --Include structurally-
exposures; lack of related diketene
adequate toxicological compounds and N-phenyl
data. derivatives.
Phenoxyethyl acrylate [48145-04-6]... NCI.................... High production volume; --Defer pending review
potential worker and of voluntary data
consumer exposures; submission through the
lack of adequate Extended HPV (EHPV)
toxicological data. Program.
Trifluoromethylbenzene [98-08-8]..... NCI.................... High production volume Defer pending review of
and potential for 1) production data
increased use; through the 2006 Toxic
potential worker Substances Control Act
exposures; lack of (TSCA) Inventory
adequate toxicological Update Rule, and 2)
data; demonstrated Organization for
toxicity in short-term Economic Cooperation
studies. and Development (OECD)
Screening Information
Data Set (SIDS)
program output.
----------------------------------------------------------------------------------------------------------------
\1\ National Institute of Environmental Health Sciences (NIEHS); National Cancer Institute (NCI)
\2\ The term ``toxicological characterization'' in this table includes studies for genotoxicity, subchronic
toxicity, and chronic toxicity/carcinogenicity as determined to be appropriate during the conceptualization
and design of a research program to address toxicological data needs. Other types of studies (e.g., metabolism
and disposition, immunotoxicity, and reproductive and developmental toxicity) may be conducted as part of a
complete toxicological characterization; however, these types of studies are not listed unless they are
specifically recommended.

[FR Doc. E6-5217 Filed 4-10-06; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.