83 FR 7488 - Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 35 (February 21, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 35 (February 21, 2018)
| Page Range | 7488-7490 | |
| FR Document | 2018-03472 |
[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)] [Notices] [Pages 7488-7490] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03472] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Toxicology Program (NTP) announces a meeting to peer review the Draft NTP Research Report on the CLARITY-BPA Core Study. This report presents the results of the core, guideline- compliant, chronic, extended-dose-range study of bisphenol A (BPA) in rats conducted as part of the CLARITY-BPA Research Program. The U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR) conducted the study under the auspices of the National Toxicology Program and prepared the draft report in collaboration with the National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting will be held at NIEHS in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/rrprp. DATES: Meeting: Tentatively scheduled for April 26, 2018, 8:30 a.m. to adjournment at approximately 5:00 p.m. Eastern Daylight Time (EDT). The meeting may end earlier or later than 5:00 p.m. EDT. The preliminary agenda of topics is available at https://ntp.niehs.nih.gov/go/rrprp and will be updated one week before the meeting. Document Availability: The draft NTP Research Report should be available by February 23, 2018, at https://ntp.niehs.nih.gov/go/rrprp. Written Public Comment Submissions: Deadline is April 12, 2018. [[Page 7489]] Registration for Oral Comments: Deadline is April 12, 2018. Registration to Attend Meeting In-person or to View Webcast: Deadline is April 26, 2018. ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Meeting web page: The draft NTP Research Report, preliminary agenda, registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/rrprp. Webcast: The URL for viewing the peer-review meeting webcast will be provided to registrants. FOR FURTHER INFORMATION CONTACT: Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email: NTP-Meetings@icf.com. SUPPLEMENTARY INFORMATION: Background: Bisphenol A (BPA) is a chemical produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. BPA also is used in the production of certain flame retardants and as a color developer in some thermal paper. BPA has been detected in air, soil, water, landfill leachate, and the human body. The primary source of human exposure to BPA is thought to be through the diet. More than 800 studies were published on the health effects of BPA between the mid-1990s and the mid-2000s. Although BPA is a well-studied chemical, few existing, chronic toxicity studies have included exposure during the perinatal period. There is also inconsistency among BPA toxicological studies with regard to findings and their interpretation for human health. Given the uncertainty regarding the potential health effects from BPA exposure, NTP, NIEHS, and U.S. Food and Drug Administration (FDA) established the consortium-based research program, called Consortium Linking Academic and Regulatory Insights on Toxicity of BPA (CLARITY-BPA). The aim of the CLARITY-BPA program was to attempt to bridge guideline-compliant research conducted at the FDA with hypothesis-based research investigations conducted by academia on the toxicity of BPA. A detailed description of the CLARITY-BPA program has been published (https://www.ncbi.nlm.nih.gov/pubmed/26232693). The CLARITY-BPA research program has two components: (1) A ``core,'' guideline- compliant, chronic study conducted at NCTR according to FDA Good Laboratory Practice (GLP) regulations (2-year perinatal only or chronic BPA exposure, including perinatal), and (2) CLARITY-BPA grantee studies of various health endpoints, conducted by NIEHS-funded researchers at academic institutions using animals born to the same exposed pregnant rats as the core GLP study. The draft NTP Research Report presents the results of the core GLP chronic study. The interpretation of biological and toxicological responses described in the draft NTP Research Report is based only on the results of the core GLP study. Integration of these data with other data from the grantee-studies conducted as part of the CLARITY-BPA research program or extrapolation of the results to other species, including characterization of hazards and risks to humans, is outside of the scope of the draft NTP Research Report. Meeting Attendance Registration: The meeting is open to the public with time set aside for oral public comment; in-person attendance at NIEHS is limited by the space available (~100 attendees). Registration for in-person attendance is on a first-come, first-served basis. After the first 100 registrants, persons will be placed on a wait list and notified should an opening become available. Registration to attend the meeting in-person or view the webcast is by April 26, 2018, at https://ntp.niehs.nih.gov/go/rrprp. The URL for the webcast will be provided in the email confirming registration. Visitor and security information for those attending in person is available at https://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities who need accommodation to view the webcast should contact Canden Byrd by phone: (919) 293-1660 or email: NTP-Meetings@icf.com. TTY users should contact the Federal TTY Relay Service at (800) 877-8339. Requests should be made at least five business days in advance of the event. Public Comment Registration: NTP invites written and oral public comments on the draft NTP Research Report. Guidelines for public comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. The deadline for submission of written comments is April 12, 2018. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Comments that address scientific or technical issues will be forwarded to the peer- review panel and NTP staff prior to the meeting. The agenda allows for one oral public comment period (12 commenters, up to 5 minutes per speaker). Registration to provide oral comments is on or before April 12, 2018, at https://ntp.niehs.nih.gov/go/rrprp. Registration is on a first-come, first-served basis. Each organization is allowed one time slot. Oral comments may be presented in person at NIEHS or by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. After the maximum number of speakers is exceeded, individuals registered to provide oral comment will be placed on a wait list (6 slots on wait list) and notified should an opening become available. Commenters will be notified after April 12, 2018, the deadline to register for oral public comments, about the actual time allotted per speaker. If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Canden Byrd by email: NTP-Meetings@icf.com by April 12, 2018. Meeting Materials: The draft NTP Research Report and preliminary agenda will be available on the NTP website at https://ntp.niehs.nih.gov/go/rrprp. The draft NTP Research Report should be available by February 23, 2018. Additional information will be posted when available or may be requested in hardcopy; contact Canden Byrd by phone: (919) 293-1660 or email: NTP-Meetings@icf.com. The preliminary meeting agenda is available on the meeting web page and will be updated one week before the meeting. Individuals are encouraged to access the meeting web page to stay abreast of the most current information regarding the meeting. Following the meeting, a report of the peer review will be prepared and made available on the NTP website. Background Information on NTP Peer-Review Panels: NTP panels are technical, scientific advisory bodies established on an ``as needed'' basis to provide independent scientific peer review and advise NTP on agents of public health concern, new/revised toxicological test methods, or other issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about [[Page 7490]] alternative methods for toxicity screening. NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide their current curriculum vitae to Canden Byrd by email: NTP-Meetings@icf.com. The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: February 7, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018-03472 Filed 2-20-18; 8:45 am] BILLING CODE 4140-01-P
![7488 Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
Name of Committee: National Institute of DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance
Neurological Disorders and Stroke Special HUMAN SERVICES Program Nos. 93.306, Comparative Medicine;
Emphasis Panel; Program Project Grant P01. 93.333, Clinical Research; 93.306, 93.333,
Date: March 12, 2018. National Institutes of Health 93.337, 93.393–93.396, 93.837–93.844,
Time: 9:00 a.m. to 5:00 p.m. 93.846–93.878, 93.892, 93.893, National
Agenda: To review and evaluate grant Center for Scientific Review; Notice of Institutes of Health, HHS)
applications. Dated: February 14, 2018.
Place: National Institutes of Health, Closed Meetings
Neuroscience Center, 6001 Executive David Clary,
Pursuant to section 10(d) of the
Boulevard, Rockville, MD 20852 (Virtual Program Analyst, Office of Federal Advisory
Federal Advisory Committee Act, as Committee Policy.
Meeting).
Contact Person: Ana Olariu, Ph.D., amended, notice is hereby given of the
[FR Doc. 2018–03440 Filed 2–20–18; 8:45 am]
Scientific Review Officer, Scientific Review following meetings.
The meetings will be closed to the BILLING CODE 4140–01–P
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208, public in accordance with the
MSC 9529, Bethesda, MD 20892–9529, 301– provisions set forth in sections
496–9223, Ana.olariu@nih.gov. DEPARTMENT OF HEALTH AND
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
HUMAN SERVICES
Name of Committee: National Institute of as amended. The grant applications and
Neurological Disorders and Stroke Special the discussions could disclose
Emphasis Panel; NeuroNEXT 1.
National Institutes of Health
confidential trade secrets or commercial
Date: March 22–23, 2018. property such as patentable material,
Time: 8:00 a.m. to 12:30 p.m.
Draft NTP Research Report on the
Agenda: To review and evaluate grant and personal information concerning CLARITY–BPA Core Study; Availability
applications. individuals associated with the grant of Document; Request for Comments;
Place: The Alexandrian, 480 King Street, applications, the disclosure of which Notice of Peer-Review Meeting
Alexandria, VA 22314. would constitute a clearly unwarranted
Contact Person: Ana Olariu, Ph.D., invasion of personal privacy. AGENCY: National Institutes of Health,
Scientific Review Officer, Scientific Review HHS.
Branch, NINDS/NIH/DHHS, Neuroscience Name of Committee: Center for Scientific ACTION: Notice.
Center, 6001 Executive Blvd., Suite 3208, Review Special Emphasis Panel; Member
MSC 9529, Bethesda, MD 20892–9529, 301– Conflict: Epidemiology of Chronic and SUMMARY: The National Toxicology
496–9223, Ana.olariu@nih.gov. Infectious Disease. Program (NTP) announces a meeting to
Date: March 5, 2018.
Name of Committee: National Institute of Time: 11:00 a.m. to 3:00 p.m. peer review the Draft NTP Research
Neurological Disorders and Stroke Special Agenda: To review and evaluate grant Report on the CLARITY–BPA Core
Emphasis Panel; NeuroNEXT 2. applications. Study. This report presents the results
Date: March 23, 2018. Place: National Institutes of Health, 6701 of the core, guideline-compliant,
Time: 1:00 p.m. to 4:00 p.m. Rockledge Drive, Bethesda, MD 20892 chronic, extended-dose-range study of
Agenda: To review and evaluate grant (Virtual Meeting).
applications.
bisphenol A (BPA) in rats conducted as
Contact Person: Heidi B. Friedman, Ph.D., part of the CLARITY–BPA Research
Place: The Alexandrian, 480 King Street, Scientific Review Officer, Center for
Alexandria, VA 22314. Program. The U.S. Food and Drug
Scientific Review, National Institutes of
Contact Person: Ana Olariu, Ph.D., Health, 6701 Rockledge Drive, Room 1012A, Administration’s National Center for
Scientific Review Officer, Scientific Review MSC 7770, Bethesda, MD 20892, 301–379– Toxicological Research (NCTR)
Branch, NINDS/NIH/DHHS, Neuroscience 5632, hfriedman@csr.nih.gov. conducted the study under the auspices
Center, 6001 Executive Blvd., Suite 3208, of the National Toxicology Program and
MSC 9529, Bethesda, MD 20892–9529, 301– Name of Committee: Center for Scientific
Review Special Emphasis Panel; Enhancing prepared the draft report in
496–9223, Ana.olariu@nih.gov.
Developmental Biology Research at AREA collaboration with the National Institute
Name of Committee: National Institute of Eligible Institutions.
Neurological Disorders and Stroke Special
of Environmental Health Sciences
Date: March 7, 2018. (NIEHS). The peer-review meeting will
Emphasis Panel; Wellstone Review. Time: 10:30 a.m. to 4:00 p.m.
Date: March 27–28, 2018. be held at NIEHS in Research Triangle
Agenda: To review and evaluate grant
Time: 8:00 a.m. to 6:00 p.m. applications. Park, NC and is open to the public.
Agenda: To review and evaluate grant Place: National Institutes of Health, 6701 Registration is requested for attendance
applications. Rockledge Drive, Bethesda, MD 20892 at the meeting either in-person or by
Place: Marriott Wardman Park, Washington (Virtual Meeting). webcast and to present oral comments.
DC Hotel, 2660 Woodley Road NW, Contact Person: Jonathan Arias, Ph.D., Information about the meeting and
Washington, DC 20008. Scientific Review Officer, Center for
Contact Person: Joel A. Saydoff, Ph.D., registration is available at https://
Scientific Review, National Institutes of ntp.niehs.nih.gov/go/rrprp.
Scientific Review Officer, Scientific Review Health, 6701 Rockledge Drive, Room 5170,
Branch, NINDS/NIH/DHHS, Neuroscience MSC 7840, Bethesda, MD 20892, 301–435– DATES:
Center, 6001 Executive Blvd., Suite 3205, 2406, ariasj@csr.nih.gov. Meeting: Tentatively scheduled for
MSC 9529, Bethesda, MD 20892–9529, 301– April 26, 2018, 8:30 a.m. to adjournment
496–9223, joel.saydoff@nih.gov. Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small at approximately 5:00 p.m. Eastern
(Catalogue of Federal Domestic Assistance Business: Biomedical Sensing, Measurement Daylight Time (EDT). The meeting may
Program Nos. 93.853, Clinical Research and Instrument. end earlier or later than 5:00 p.m. EDT.
Related to Neurological Disorders; 93.854, Date: March 15–16, 2018. The preliminary agenda of topics is
Biological Basis Research in the Time: 8:00 a.m. to 3:00 p.m.
Neurosciences, National Institutes of Health, available at https://ntp.niehs.nih.gov/
Agenda: To review and evaluate grant go/rrprp and will be updated one week
daltland on DSKBBV9HB2PROD with NOTICES
HHS) applications. before the meeting.
Dated: February 15, 2018. Place: Bahia Resort Hotel, 998 West
Document Availability: The draft NTP
Sylvia L. Neal, Mission Bay Drive, San Diego, CA 92109.
Contact Person: Inna Gorshkova, Ph.D., Research Report should be available by
Program Analyst, Office of Federal Advisory February 23, 2018, at https://
Scientific Review Officer, Center for
Committee Policy. ntp.niehs.nih.gov/go/rrprp.
Scientific Review, National Institutes of
[FR Doc. 2018–03474 Filed 2–20–18; 8:45 am] Health, 6701 Rockledge Drive, Bethesda, MD Written Public Comment
BILLING CODE 4140–01–P 20892, 301–435–1784, gorshkoi@csr.nih.gov. Submissions: Deadline is April 12, 2018.
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![7490 Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
alternative methods for toxicity Agenda: To review and evaluate contract SUMMARY: The National Park Service is
screening. NTP welcomes nominations proposals. soliciting comments on the significance
of scientific experts for upcoming Place: Holiday Inn National Airport Hotel, of properties nominated before January
panels. Scientists interested in serving 2650 Jefferson Davis Highway, Arlington, VA 20, 2018, for listing or related actions in
22202.
on an NTP panel should provide their Contact Person: William J. Johnson, Ph.D.,
the National Register of Historic Places.
current curriculum vitae to Canden Scientific Review Officer, Office of Scientific DATES: Comments should be submitted
Byrd by email: NTP-Meetings@icf.com. Review/DERA, National Heart, Lung, and by March 8, 2018.
The authority for NTP panels is Blood Institute, 6701 Rockledge Drive, Room ADDRESSES: Comments may be sent via
provided by 42 U.S.C. 217a; section 222 7178, Bethesda, MD 20892–7924, 301–827– U.S. Postal Service and all other carriers
of the Public Health Service Act, as 7938, johnsonw@nhlbi.nih.gov. to the National Register of Historic
amended. The panel is governed by the Name of Committee: National Heart, Lung, Places, National Park Service, 1849 C St.
Federal Advisory Committee Act, as and Blood Institute Special Emphasis Panel; NW, MS 7228, Washington, DC 20240.
amended (5 U.S.C. Appendix 2), which Jackson Heart Study Training and Education
Center (TEC). SUPPLEMENTARY INFORMATION: The
sets forth standards for the formation properties listed in this notice are being
and use of advisory committees. Date: March 14, 2018.
Time: 9:00 a.m. to 9:30 a.m. considered for listing or related actions
Dated: February 7, 2018. Agenda: To review and evaluate contract in the National Register of Historic
Brian R. Berridge, proposals. Places. Nominations for their
Associate Director, National Toxicology Place: Holiday Inn National Airport Hotel, consideration were received by the
Program. 2650 Jefferson Davis Highway, Arlington, VA National Park Service before January 20,
22202. 2018. Pursuant to section 60.13 of 36
[FR Doc. 2018–03472 Filed 2–20–18; 8:45 am]
Contact Person: William J. Johnson, Ph.D.,
BILLING CODE 4140–01–P Scientific Review Officer, Office of Scientific
CFR part 60, written comments are
Review/DERA, National Heart, Lung, and being accepted concerning the
Blood Institute, 6701 Rockledge Drive, Room significance of the nominated properties
DEPARTMENT OF HEALTH AND 7178, Bethesda, MD 20892–7924, 301–827– under the National Register criteria for
HUMAN SERVICES 7938, johnsonw@nhlbi.nih.gov. evaluation.
Name of Committee: National Heart, Lung, Before including your address, phone
National Institutes of Health and Blood Institute Special Emphasis Panel; number, email address, or other
Jackson Heart Study Coordinating Center personal identifying information in your
National Heart, Lung, and Blood (CC). comment, you should be aware that
Institute; Notice of Closed Meetings Date: March 14, 2018. your entire comment—including your
Time: 9:30 a.m. to 5:00 p.m. personal identifying information—may
Pursuant to section 10(d) of the Agenda: To review and evaluate contract
Federal Advisory Committee Act, as be made publicly available at any time.
proposals.
amended (5 U.S.C. App.), notice is Place: Holiday Inn National Airport Hotel,
While you can ask us in your comment
hereby given of the following meetings. 2650 Jefferson Davis Highway, Arlington, VA to withhold your personal identifying
22202. information from public review, we
The meetings will be closed to the
Contact Person: William J. Johnson, Ph.D., cannot guarantee that we will be able to
public in accordance with the
Scientific Review Officer, Office of Scientific do so.
provisions set forth in sections Review/DERA, National Heart, Lung, and Nominations submitted by State
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Blood Institute, 6701 Rockledge Drive, Room Historic Preservation Officers:
as amended. The contract proposals and 7178, Bethesda, MD 20892–7924, 301–827–
the discussions could disclose 7938, johnsonw@nhlbi.nih.gov. ARIZONA
confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance Maricopa County
property such as patentable material, Program Nos. 93.233, National Center for
and personal information concerning Sleep Disorders Research; 93.837, Heart and Ponderosa II, 602 S. Edgewater Dr., Mesa,
individuals associated with the contract Vascular Diseases Research; 93.838, Lung SG100002146
proposals, the disclosure of which Diseases Research; 93.839, Blood Diseases ILLINOIS
would constitute a clearly unwarranted and Resources Research, National Institutes
of Health, HHS) Coles County
invasion of personal privacy.
Dated: February 14, 2018. Burgess–Osborne Memorial Auditorium,
Name of Committee: National Heart, Lung, 1701 Wabash Ave., Mattoon, SG100002149
and Blood Institute Special Emphasis Panel; Michelle Trout,
Jackson Heart Study Field Center (FC). Program Analyst, Office of Federal Advisory Kankakee County
Date: March 14, 2018. Committee Policy. Kankakee Downtown Historic District,
Time: 8:00 a.m. to 8:30 a.m. [FR Doc. 2018–03441 Filed 2–20–18; 8:45 am] Roughly bounded by West Ave., Oak,
Agenda: To review and evaluate contract Indiana & Station Sts., Kankakee,
BILLING CODE 4140–01–P
proposals. SG100002150
Place: Holiday Inn National Airport Hotel,
2650 Jefferson Davis Highway, Arlington, VA KENTUCKY
22202. DEPARTMENT OF THE INTERIOR Allen County
Contact Person: William J. Johnson, Ph.D.,
National Park Service Halcomb, Dr. Francis Joseph (F.J.) Jr., House,
Scientific Review Officer, Office of Scientific
253 Franklin Rd., Scottsville, SG100002152
Review/DERA, National Heart, Lung, and
[NPS–WASO–NRNHL–24925;
Blood Institute, 6701 Rockledge Drive, Room Campbell County
PPWOCRADI0, PCU00RP14.R50000]
daltland on DSKBBV9HB2PROD with NOTICES
7178, Bethesda, MD 20892–7924, 301–827– Bonnie Leslie Historic District, Bounded by
7938, johnsonw@nhlbi.nih.gov. Memorial Pkwy., Taylor, Wilson, Berry &
National Register of Historic Places;
Name of Committee: National Heart, Lung, Notification of Pending Nominations Anspaugh Aves., Bellevue, SG100002153
and Blood Institute Special Emphasis Panel;
and Related Actions Edmonson County
Jackson Heart Study Community Engagement
Center (CEC). AGENCY: National Park Service, Interior. Chalybeate Springs Hotel Springhouse, 2327
Date: March 14, 2018. ACTION: Notice.
Chalybeate Rd., Smiths Grove vicinity,
Time: 8:30 a.m. to 9:00 a.m. SG100002154
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Document Created: 2018-02-21 01:48:28
Document Modified: 2018-02-21 01:48:28
| 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. | |
| Dates | Meeting: Tentatively scheduled for April 26, 2018, 8:30 a.m. to adjournment at approximately 5:00 p.m. Eastern Daylight Time (EDT). The meeting may end earlier or later than 5:00 p.m. EDT. The preliminary agenda of topics is available at https://ntp.niehs.nih.gov/go/rrprp and will be updated one week before the meeting. | |
| Contact | Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email: [email protected] | |
| FR Citation | 83 FR 7488 |
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