National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Notice of Availability of a Revised List of Recommended Reference Substances for Validation of In Vitro Estrogen and Androgen Receptor Binding and Transcriptional Activation Assays, 56997-56998 [E6-15972]

Download as PDF Federal Register / Vol. 71, No. 188 / Thursday, September 28, 2006 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel; Assays and Detectors. Date: October 25–26, 2006. Time: 6 p.m. to 7 p.m. Agenda: To review and evaluate grant applications. Place: Clarion Hotel Bethesda Park, 8400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Geoffrey White, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD 20892, (301) 435– 1735, whitege@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.983, National Institutes of Health, HHS) Dated: September 19, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8331 Filed 9–27–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Notice of Availability of a Revised List of Recommended Reference Substances for Validation of In Vitro Estrogen and Androgen Receptor Binding and Transcriptional Activation Assays National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Notice of the availability of a revised list of recommended reference substances. sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: NICEATM announces the availability of an addendum to the report, ‘‘Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays’’ [NIH Publication 03–4503]. The addendum describes the rationale for revisions to the original list of recommended reference substances for validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays. SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 20:16 Sep 27, 2006 Jkt 208001 Background In April 2000, the Environmental Protection Agency (EPA) asked ICCVAM to evaluate the validation status of in vitro ER and AR binding and TA assays that were proposed as possible components of the EPA Endocrine Disruptor Screening Program Tier 1 screening battery. ICCVAM agreed to evaluate these test methods based on their potential interagency applicability and public health significance. NICEATM subsequently compiled available data and information on in vitro ER and AR binding and TA assays in four draft Background Review Documents (BRDs) (available at https:// iccvam.niehs.nih.gov/methods/ endocrine.htm). In collaboration with the ICCVAM Endocrine Disruptor Working Group, NICEATM organized an independent scientific evaluation of the validation status of the four types of in vitro endocrine disruptor screening test methods on May 20–21, 2002, in Research Triangle Park, NC (Federal Register, Vol. 66, No. 57, pp. 16278– 16279, March 23, 2001 and Federal Register, Vol. 66, No. 67, pp. 16415– 16416, April 5, 2002, available at https:// iccvam.niehs.nih.gov/methods/ endocrine.htm). The final BRDs and the ICCVAM Test Method Evaluation Report, which includes the expert panel report, public comments, and other relevant documents, were published in May 2003 and announced in the Federal Register notice (Vol. 68, No. 106, pp. 33171–33172, June 3, 2003, available at https://iccvam.niehs.nih.gov/methods/ endocrine.htm). NICEATM recently reviewed the commercial availability and cost for the 78 substances recommended by ICCVAM for use in in vitro ER and AR binding and TA validation studies. A minimum of 44 substances are recommended for AR binding and TA assays, while a minimum of 53 substances are recommended for ER binding and TA assays. This review indicated that three substances (anastrazole, CGS 18320B, and fadrozole) are not commercially available, one substance has restricted commercial availability (ICI 182,780) and six others (actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, methyltrienolone, 12-Otetradecanoylphorbol-13-acetate, zearalenone) have costs that are considered excessive. ICCVAM has replaced the four substances, which are not commercially available or have restricted availability, with ones having similar ER and AR activity profiles (4- PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 56997 hydroxyandrostenedione, chrysin, dicofol, raloxifene HCl). 19nortestosterone and resveratrol were identified as replacements for two of the expensive substances, metyltrienolone and zearalenone respectively. NICEATM sought to replace four of the highly priced substances (actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, 12-O-tetradecanoylphorbol-13-acetate), but was unable to identify suitable replacements because of their unique activity profiles and/or chemical/ physical properties. The proposed revisions were made available for public comment in March 2006 (Federal Register, Vol. 71, No. 51, pp. 13597– 13598, March 16, 2006) and no comments were received. The final revised list of 78 reference substances recommended for validation of in vitro ER and AR binding and TA validation studies and a discussion about the revisions are now available in the document, ‘‘Addendum to the ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays.’’ The addendum is available on the ICCVAM/ NICEATM Web site at https:// iccvam.niehs.nih.gov see ‘‘Test Method Evaluations’’ or by contacting NICEATM (requests should be sent by mail, fax, or e-mail to Dr. William S. Stokes, NICEATM Director, NIEHS, P. O. Box 12233, MD EC–17, Research Triangle Park, NC, 27709, (phone) 919–541– 2384, (fax) 919–541–0947, (e-mail) niceatm@niehs.nih.gov.). Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and E:\FR\FM\28SEN1.SGM 28SEN1 56998 Federal Register / Vol. 71, No. 188 / Thursday, September 28, 2006 / Notices NICEATM can be found at the following Web site: https:// www.iccvam.niehs.nih.gov. Dated: September 18, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–15972 Filed 9–27–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG 2006–25080] Medical and Physical Evaluation Guidelines for Merchant Mariner Credentials Notice of availability; request for comments. sroberts on PROD1PC70 with NOTICES ACTION: SUMMARY: The Coast Guard announces the availability of, and seeks public comment on, a draft Navigation and Vessel Inspection Circular (NVIC) to replace the existing NVIC 2–98, ‘‘Physical Evaluation Guidelines for Merchant Mariner’s Documents and Licenses.’’ The new proposed NVIC is entitled ‘‘Medical and Physical Evaluation Guidelines for Merchant Mariner Credentials.’’ It will be officially numbered if and when it becomes effective. The contents of this NVIC were developed from recommendations and input provided by the Merchant Marine Personnel Advisory Committee (MERPAC) and experienced maritime community medical practitioners. A copy of the proposed NVIC has been posted to the public docket for this notice, and it is available as described under ADDRESSES. DATES: Comments and related material must reach the Docket Management Facility on or before November 27, 2006. ADDRESSES: The proposed NVIC is available on the Internet at https:// dms.dot.gov, under this docket number [USCG 2006–25080]. It is also available from Mr. Mark Gould, Maritime Personnel Qualifications Division, Office of Operating and Environmental Standards, Commandant (G–PSO–1), U.S. Coast Guard Headquarters, telephone 202–372–1409, or e-mail address: Mark.C.Gould@uscg.mil. The Coast Guard encourages you to submit comments. The most helpful comments will include the specific section of the proposed NVIC to which each comment applies, as well as the reason for each comment. Comments VerDate Aug<31>2005 20:16 Sep 27, 2006 Jkt 208001 should be identified by USCG docket number USCG–2006–25080. Please include your name and address with your comments and submit using ONE of the following methods: (1) Web site: https://dms.dot.gov. (2) Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL–401, Washington, DC 20590–0001. (3) Fax: 202–493–2251. (4) Delivery: Room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366– 9329. (5) Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions on the Web site. The Docket Management Facility maintains the public docket for this notice. Comments and related material received from the public, as well as documents mentioned in this notice (including the proposed NVIC), will become part of this docket and will be available for inspection or copying at room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC 20590–0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Copies of the docket may also be viewed on the internet at: https://dms.dot.gov and https://www.regulations.gov. If you mail or deliver your comments and material, they must be on 81⁄2-by11-inch paper, and the quality of the copy should be clear enough for copying and scanning. If you mail your comments and material and would like to know whether the Docket Management Facility received them, please enclose a stamped, self-addressed postcard or envelope. The Coast Guard will consider all comments and material received during the 60-day comment period. For questions on this notice or on the proposed NVIC, e-mail or call Mr. Gould where indicated under ADDRESSES. For questions on viewing or submitting material to the docket, call Ms. Renee V. Wright, Program Manager, Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590–0001; telephone (202) 493–0402. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: What action is the Coast Guard taking? The proposed NVIC contains revised guidelines for evaluating the physical and medical conditions of applicants for merchant mariner’s documents (MMD), PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 licenses, certificates of registry and STCW endorsements, collectively referred to as ‘‘credential(s).’’ The purpose of the proposed NVIC is to replace the existing NVIC 2–98. It also provides guidance for evaluating the physical and medical conditions of applicants for merchant mariner credentials (MMCs), if and when the Coast Guard begins issuing MMCs as proposed in 71 FR 29462, ‘‘Consolidation of Merchant Mariner Qualification Credentials.’’ Why is the Coast Guard taking this action? The International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended (STCW) requires each party to establish standards of medical fitness for seafarers. Title 46 United States Code, Subtitle II, Part E, and Title 46 Code of Federal Regulations (CFR) subpart B require that mariners be physically able to perform their duties, using terms such as ‘‘general physical condition,’’ ‘‘good health’’ and ‘‘of sound health.’’ Title 46 CFR parts 401 and 402 contain special requirements for registration as a Great Lakes Pilot, including the requirement to ‘‘pass a physical examination given by a licensed medical doctor.’’ None of these references contain specific standards, with the exception of visual acuity and color vision, for determining if mariners are physically and medically qualified. The lack of specificity in the above statutes and regulations has led to confusion and unnecessary delays in processing credential applications as well as inconsistent evaluations by medical practitioners conducting examinations of credential applicants. Moreover, it has caused confusion on the part of Coast Guard personnel charged with determining whether a credential should be issued. The proposed NVIC provides the specificity that the above statutes and regulations lack. It details the specific medical and physical conditions that are potentially disqualifying, and the data recommended for evaluation of each of these conditions. This is expected to reduce the inconsistency and subjectivity of the medical evaluation process and eliminate the guesswork that mariners may currently encounter as to what specific physical and medical information is needed to process their applications. In addition, there are public safety risks associated with some medical and physical conditions, particularly when these conditions may result in the sudden incapacitation of mariners on vessels. These conditions can be the E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 71, Number 188 (Thursday, September 28, 2006)]
[Notices]
[Pages 56997-56998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15972]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Notice of 
Availability of a Revised List of Recommended Reference Substances for 
Validation of In Vitro Estrogen and Androgen Receptor Binding and 
Transcriptional Activation Assays

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

ACTION: Notice of the availability of a revised list of recommended 
reference substances.

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

SUMMARY: NICEATM announces the availability of an addendum to the 
report, ``Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for 
Detecting Potential Endocrine Disruptors: Estrogen Receptor and 
Androgen Receptor Binding and Transcriptional Activation Assays'' [NIH 
Publication 03-4503]. The addendum describes the rationale for 
revisions to the original list of recommended reference substances for 
validation of in vitro estrogen receptor (ER) and androgen receptor 
(AR) binding and transcriptional activation (TA) assays.

SUPPLEMENTARY INFORMATION:

Background

    In April 2000, the Environmental Protection Agency (EPA) asked 
ICCVAM to evaluate the validation status of in vitro ER and AR binding 
and TA assays that were proposed as possible components of the EPA 
Endocrine Disruptor Screening Program Tier 1 screening battery. ICCVAM 
agreed to evaluate these test methods based on their potential 
interagency applicability and public health significance. NICEATM 
subsequently compiled available data and information on in vitro ER and 
AR binding and TA assays in four draft Background Review Documents 
(BRDs) (available at https://iccvam.niehs.nih.gov/methods/
endocrine.htm).
    In collaboration with the ICCVAM Endocrine Disruptor Working Group, 
NICEATM organized an independent scientific evaluation of the 
validation status of the four types of in vitro endocrine disruptor 
screening test methods on May 20-21, 2002, in Research Triangle Park, 
NC (Federal Register, Vol. 66, No. 57, pp. 16278-16279, March 23, 2001 
and Federal Register, Vol. 66, No. 67, pp. 16415-16416, April 5, 2002, 
available at https://iccvam.niehs.nih.gov/methods/endocrine.htm).
    The final BRDs and the ICCVAM Test Method Evaluation Report, which 
includes the expert panel report, public comments, and other relevant 
documents, were published in May 2003 and announced in the Federal 
Register notice (Vol. 68, No. 106, pp. 33171-33172, June 3, 2003, 
available at https://iccvam.niehs.nih.gov/methods/endocrine.htm).
    NICEATM recently reviewed the commercial availability and cost for 
the 78 substances recommended by ICCVAM for use in in vitro ER and AR 
binding and TA validation studies. A minimum of 44 substances are 
recommended for AR binding and TA assays, while a minimum of 53 
substances are recommended for ER binding and TA assays. This review 
indicated that three substances (anastrazole, CGS 18320B, and 
fadrozole) are not commercially available, one substance has restricted 
commercial availability (ICI 182,780) and six others (actinomycin D, 
hydroxyflutamide, 4-hydroxytamoxifen, methyltrienolone, 12-O-
tetradecanoylphorbol-13-acetate, zearalenone) have costs that are 
considered excessive. ICCVAM has replaced the four substances, which 
are not commercially available or have restricted availability, with 
ones having similar ER and AR activity profiles (4-
hydroxyandrostenedione, chrysin, dicofol, raloxifene HCl). 19-
nortestosterone and resveratrol were identified as replacements for two 
of the expensive substances, metyltrienolone and zearalenone 
respectively. NICEATM sought to replace four of the highly priced 
substances (actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, 12-O-
tetradecanoylphorbol-13-acetate), but was unable to identify suitable 
replacements because of their unique activity profiles and/or chemical/
physical properties. The proposed revisions were made available for 
public comment in March 2006 (Federal Register, Vol. 71, No. 51, pp. 
13597-13598, March 16, 2006) and no comments were received. The final 
revised list of 78 reference substances recommended for validation of 
in vitro ER and AR binding and TA validation studies and a discussion 
about the revisions are now available in the document, ``Addendum to 
the ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential 
Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding 
and Transcriptional Activation Assays.'' The addendum is available on 
the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov see ``Test 
Method Evaluations'' or by contacting NICEATM (requests should be sent 
by mail, fax, or e-mail to Dr. William S. Stokes, NICEATM Director, 
NIEHS, P. O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, 
(phone) 919-541-2384, (fax) 919-541-0947, (e-mail) 
niceatm@niehs.nih.gov.).

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use or generate 
toxicological information. ICCVAM conducts technical evaluations of 
new, revised, and alternative methods with regulatory applicability and 
promotes the scientific validation and regulatory acceptance of 
toxicological test methods that more accurately assess the safety and 
hazards of chemicals and products and that refine, reduce, or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285) 
establishes ICCVAM as a permanent interagency committee of the NIEHS 
under the NICEATM. NICEATM administers the ICCVAM and provides 
scientific and operational support for ICCVAM-related activities. 
NICEATM and ICCVAM work collaboratively to evaluate new and improved 
test methods applicable to the needs of Federal agencies. Additional 
information about ICCVAM and

[[Page 56998]]

NICEATM can be found at the following Web site: https://
www.iccvam.niehs.nih.gov.

    Dated: September 18, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E6-15972 Filed 9-27-06; 8:45 am]
BILLING CODE 4140-01-P
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