Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting, 6568-6569 [2012-2921]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 6568 Federal Register / Vol. 77, No. 26 / Wednesday, February 8, 2012 / Notices groups will be on the available clinical data from both randomized clinical trials and other studies of the efficacy of opioid analgesics, and comparison of that data to the data from studies of nonopioid analgesics used in the treatment of CNCP. Date and Time: The public workshop will be held on May 30, 2012, from 1 p.m. to 5:15 p.m. and on May 31, 2012, from 8:30 a.m. to 5 p.m. Location: The workshop will be held at the Natcher Auditorium, Natcher Conference Center, National Institutes of Health Campus, 45 Center Dr., Bethesda, MD 20892. Contacts: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6178, Silver Spring, MD 20993–0002, (301) 796–3519; or Matthew Sullivan, Center for Drug Evaluation, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3160, Silver Spring, MD 20993–0002, (301) 796–1245. Registration: If you wish to attend the workshop or provide oral comments during the open session of the meeting, please email your registration to CDER_ChronicPain_Workshop @FDA.HHS.GOV by May 15, 2012. Those without email access may register by contacting one of the persons listed in the Contacts section of the document. Please provide complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number. Registration is free and will be on a firstcome, first-served basis. Registrants will receive confirmation once they have been accepted for the workshop. Onsite registration on the day of the meeting will be based on space availability. If registration reaches maximum capacity, FDA will post a notice closing the meeting registration for the workshop at: https://www.fda.gov/Drugs/NewsEvents/ ucm283979.htm. An open session of the meeting will be held between 3:45 p.m. and 5 p.m. on May 30, 2012, during which time public comments will be accepted. We will try to accommodate all persons who wish to speak at this open session; however, the duration of each speaker’s testimony may be limited by time constraints. Comments: Submit either electronic or written comments by August 1, 2012. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket VerDate Mar<15>2010 14:54 Feb 07, 2012 Jkt 226001 number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. If you need special accommodations due to a disability, contact Mary Gross or Matthew Sullivan (see Contacts) at least 7 days in advance. SUPPLEMENTARY INFORMATION: I. Introduction CNCP is a major cause of pain and disability for millions of Americans. The prescribing of opioids for pain has risen steadily in the United States over the past two decades, including the prescribing of opioids to treat CNCP. Questions have been raised about the efficacy of opioids in the treatment of CNCP, including which patients benefit from the chronic use of opioids, the durability of analgesia provided by opioid analgesics, and how best to manage the use of these drugs. Addressing this uncertainty begins with a discussion of the available scientific data on the use of opioids in chronic painful conditions. The discussion will include health care professionals, clinical investigators, regulators, manufacturers, patients, caregivers, and advocacy groups. Where gaps in our knowledge are identified, it will be important to discuss the research that needs to be undertaken to better understand the effectiveness of all analgesics for the treatment of chronic non-cancer pain, and opioid analgesics in particular. The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP. FDA will be considering the following questions during the workshop: 1. What is currently known about the mechanisms of chronic pain? PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 2. How might this knowledge affect the use of pharmaceuticals chronically for the treatment of pain? 3. What is known regarding use of pain biomarkers (e.g., phenotyping, imaging, genotyping)? 4. What is known about the sources of chronic pain, the populations affected by it, and trends in current use of pharmaceuticals in its treatment? 5. What data are available from controlled trials that have examined the use of pharmaceuticals in the treatment of chronic pain? 6. What data are available from other sources on the use of pharmaceuticals in the treatment of chronic pain? 7. Can populations and individuals who would benefit from chronic use of pharmaceuticals be identified? 8. Can individuals at high risk for adverse effects be identified? 9. What more should be known about the use of pharmaceuticals to treat chronic pain? FDA will post the agenda and additional workshop background material approximately 5 days before the workshop at https://www.fda.gov/ Drugs/NewsEvents/ucm283979.htm. II. Transcripts Please be advised that approximately 30 days after the public workshop, a transcript will be available. It will be accessible at https://www.regulations.gov and may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: February 2, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–2757 Filed 2–7–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting National Institutes of Health, Department of Health and Human Services. ACTION: Notice. AGENCY: In accordance with the National Environmental Policy Act, 42 SUMMARY: E:\FR\FM\08FEN1.SGM 08FEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 26 / Wednesday, February 8, 2012 / Notices U.S.C. 4321–4347, the National Institutes of Health (NIH) is issuing this notice to advise the public that an environmental impact statement will be prepared for the National Institutes of Health, Bethesda Campus Master Plan, Bethesda, Maryland. DATES: The Scoping Meeting is planned for 6 p.m. on February 28th, 2012. Scoping comments must be postmarked no later than March 26, 2012 to ensure they are considered. ADDRESSES: The Scoping Meeting will be held at 6001 Executive Plaza, Conference Room D, Bethesda, Maryland. All comments and questions on the Scoping Meeting and Environmental Impact Statement should be directed to Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/ 2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone (301) 496– 7775; fax (301) 480–8056; or email nihnepa@mail.nih.gov. FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone (301) 496– 7775; fax (301) 480–8056; or email nihnepa@mail.nih.gov. SUPPLEMENTARY INFORMATION: NIH is the focal point of the federal government for health research and is one of the world’s foremost biomedical research institutions. The NIH mission is to discover new knowledge that will lead to better health for all. To achieve that mission, nearly eighty percent of the total NIH budget is expended in the form of peer-reviewed, competitively awarded research grants, cooperative agreements, and contracts to nearly 50,000 principal investigators at more than 1,700 institutions across the country including universities, medical schools, and hospitals. In addition, some 2,000 research projects are conducted in the NIH intramural laboratories and at the NIH Clinical Center. Research is conducted at both the basic and clinical levels, encompassing studies related to the prevention, diagnosis, treatment and cure of the many diseases that afflict the men, women and children of the world. In addition, the basic research supported by NIH provides the foundation for the nation’s pharmaceutical and biotechnology industries. As one measure of the agency’s excellence in research, it should be noted that NIH-supported VerDate Mar<15>2010 14:54 Feb 07, 2012 Jkt 226001 investigators won over 107 Nobel Prizes from 1939 to 2002. A Master Plan is an integrated series of documents that present in graphic, narrative, and tabular form the current composition of NIH campuses and the plan for their orderly and comprehensive development over a 20year period. The plan provides guidance in coordinating the physical development of NIH campuses, including building locations, utility capacities, road alignments, parking facilities, and the treatment of open spaces. General design guidelines are also used to provide detailed guidance for the placement and design of physical improvements. The proposed action is to develop a long-range physical master plan for NIH. The plan will cover a 20-year planning period and address the future development of the NIH site, including placement of future construction; vehicular and pedestrian circulation; parking within the property boundaries; open space in and around the campus; required setbacks; historic properties; natural and scenic resources; noise; and lighting. The plan will examine potential growth in NIH personnel and consequent construction of space over the planning period. Future construction on the site could include such facilities as new animal holding, research laboratories, and support facilities. In accordance with 40 CFR 1500–1508 and DHHS environmental procedures, NIH will prepare an Environmental Impact Statement (EIS) for the proposed master plan. The EIS will evaluate the impacts of the master plan should development occur as proposed. Among the items the EIS will examine are the implications of the master plan on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in the planning and environmental review process, NIH is inviting oral and written comments on the master plan and related environmental issues. The NIH will be sponsoring a public Scoping Meeting to provide individuals an opportunity to share their ideas on the master planning effort, including recommended alternatives and environmental issues the EIS should consider. All interested parties are encouraged to attend. NIH has established a 45-day public comment period for the scoping process. PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 6569 Dated: February 2, 2012. Daniel G. Wheeland, Director, Office of Research Facilities Development and Operations, National Institutes of Health. [FR Doc. 2012–2921 Filed 2–7–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the 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 Institute of Environmental Health Sciences, Special Emphasis Panel, Environmental Stem Cells Research. Date: February 29–March 2, 2012. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Radisson Hotel, 150 Park Drive, Ballroom ABC, Research Triangle Park, NC 27709. Contact Person: Teresa Nesbitt, Ph.D., DVM, Chief, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, (919) 541– 7571, nesbittt@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: January 31, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–2871 Filed 2–7–12; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Notices]
[Pages 6568-6569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2921]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Intent To Prepare an Environmental Impact Statement and 
Notice of Scoping Meeting

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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

SUMMARY: In accordance with the National Environmental Policy Act, 42

[[Page 6569]]

U.S.C. 4321-4347, the National Institutes of Health (NIH) is issuing 
this notice to advise the public that an environmental impact statement 
will be prepared for the National Institutes of Health, Bethesda Campus 
Master Plan, Bethesda, Maryland.

DATES: The Scoping Meeting is planned for 6 p.m. on February 28th, 
2012. Scoping comments must be postmarked no later than March 26, 2012 
to ensure they are considered.

ADDRESSES: The Scoping Meeting will be held at 6001 Executive Plaza, 
Conference Room D, Bethesda, Maryland. All comments and questions on 
the Scoping Meeting and Environmental Impact Statement should be 
directed to Valerie Nottingham, Chief, Environmental Quality Branch, 
Division of Environmental Protection, Office of Research Facilities, 
NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 
(301) 496-7775; fax (301) 480-8056; or email nihnepa@mail.nih.gov.

FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Chief, 
Environmental Quality Branch, Division of Environmental Protection, 
Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, 
Bethesda, Maryland 20892, telephone (301) 496-7775; fax (301) 480-8056; 
or email nihnepa@mail.nih.gov.

SUPPLEMENTARY INFORMATION: NIH is the focal point of the federal 
government for health research and is one of the world's foremost 
biomedical research institutions. The NIH mission is to discover new 
knowledge that will lead to better health for all. To achieve that 
mission, nearly eighty percent of the total NIH budget is expended in 
the form of peer-reviewed, competitively awarded research grants, 
cooperative agreements, and contracts to nearly 50,000 principal 
investigators at more than 1,700 institutions across the country 
including universities, medical schools, and hospitals. In addition, 
some 2,000 research projects are conducted in the NIH intramural 
laboratories and at the NIH Clinical Center. Research is conducted at 
both the basic and clinical levels, encompassing studies related to the 
prevention, diagnosis, treatment and cure of the many diseases that 
afflict the men, women and children of the world. In addition, the 
basic research supported by NIH provides the foundation for the 
nation's pharmaceutical and biotechnology industries. As one measure of 
the agency's excellence in research, it should be noted that NIH-
supported investigators won over 107 Nobel Prizes from 1939 to 2002.
    A Master Plan is an integrated series of documents that present in 
graphic, narrative, and tabular form the current composition of NIH 
campuses and the plan for their orderly and comprehensive development 
over a 20-year period. The plan provides guidance in coordinating the 
physical development of NIH campuses, including building locations, 
utility capacities, road alignments, parking facilities, and the 
treatment of open spaces. General design guidelines are also used to 
provide detailed guidance for the placement and design of physical 
improvements.
    The proposed action is to develop a long-range physical master plan 
for NIH. The plan will cover a 20-year planning period and address the 
future development of the NIH site, including placement of future 
construction; vehicular and pedestrian circulation; parking within the 
property boundaries; open space in and around the campus; required 
setbacks; historic properties; natural and scenic resources; noise; and 
lighting. The plan will examine potential growth in NIH personnel and 
consequent construction of space over the planning period. Future 
construction on the site could include such facilities as new animal 
holding, research laboratories, and support facilities.
    In accordance with 40 CFR 1500-1508 and DHHS environmental 
procedures, NIH will prepare an Environmental Impact Statement (EIS) 
for the proposed master plan. The EIS will evaluate the impacts of the 
master plan should development occur as proposed. Among the items the 
EIS will examine are the implications of the master plan on community 
infrastructure, including, but not limited to, utilities, storm water 
management, traffic and transportation, and other public services. To 
ensure that the public is afforded the greatest opportunity to 
participate in the planning and environmental review process, NIH is 
inviting oral and written comments on the master plan and related 
environmental issues.
    The NIH will be sponsoring a public Scoping Meeting to provide 
individuals an opportunity to share their ideas on the master planning 
effort, including recommended alternatives and environmental issues the 
EIS should consider. All interested parties are encouraged to attend. 
NIH has established a 45-day public comment period for the scoping 
process.

    Dated: February 2, 2012.
Daniel G. Wheeland,
Director, Office of Research Facilities Development and Operations, 
National Institutes of Health.
[FR Doc. 2012-2921 Filed 2-7-12; 8:45 am]
BILLING CODE 4140-01-P

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