Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 40320-40321 [E7-14215]

Download as PDF mstockstill on PROD1PC66 with NOTICES 40320 Federal Register / Vol. 72, No. 141 / Tuesday, July 24, 2007 / Notices The conference will begin at 8:30 a.m. on September 5 and 6 and will be open to the public. Vitamin D is a unique nutrient because its needs can be met in two distinct ways: by endogenous production from sun exposure or from foods and dietary supplements. In addition to calcium metabolism, accumulating evidence indicates other roles in human health, including immune function, reduction of inflammation, and effects on cell proliferation, differentiation, and programmed cell death. Even as its importance to health expands, concerns about the sufficiency of vitamin D in the population are growing. Reports of rickets (the classic vitamin D deficiency disease) and low blood levels of the biomarker of vitamin D status— 25(OH)D—among various subgroups of the U.S. population raise concerns about current public health approaches to ensure vitamin D adequacy. The first NIH conference on Vitamin D and Health in the 21st Century was held in 2003. Subtitled Bone and Beyond, it considered knowledge regarding the measurement and maintenance of vitamin D status and the development of programs to reduce the prevalence of insufficiency. It also identified a number of research needs, including the following: • Better definitions of vitamin D status with meaningful cutoff values and biomarkers that have functional relevance and validated assessment methods; • Dose-response relationships between sunlight exposure and endogenous vitamin D synthesis with specific health outcomes in various racial/ethnic groups; • Investigations of genetic polymorphisms to identify tissuespecific roles of vitamin D; • Exploration of the relationships of obesity and weight loss on vitamin D status; • Improved methods for assessing vitamin D intakes, particularly from fortified foods and supplements; • Biomarkers and functional outcomes for bone and non-bone tissue that reflect vitamin D status; and • A systematic evidence-based review to determine the current state of knowledge. Progress has been made in addressing many of these research needs. However, since the 2003 conference, new issues have been raised. For example, reports indicate a growing prevalence of vitamin D insufficiency/deficiency in the U.S. population. They also suggest that vitamin D inadequacy occurs at blood levels previously viewed as VerDate Aug<31>2005 17:50 Jul 23, 2007 Jkt 211001 adequate. It is time to assess current knowledge of the efficacy and safety of vitamin D to identify new research needs that will help ensure optimal vitamin D status across the life cycle. For this reason, the NIH Office of Dietary Supplements will sponsor this conference on Vitamin D and Health in the 21st Century—An Update, September 5–6, 2007, in Bethesda, Maryland. The goals of the conference are as follows: • Evaluation of the efficacy and safety of vitamin D across the life cycle, considering the evidence-based review produced through the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center Program and research and related tools that have become available since the 2003 NIH conference, Vitamin D and Health in the 21st Century—Bone and Beyond; • Presentation of current data/ research on vitamin D status, sources of vitamin D, and functional outcomes across the life cycle; and • Identification of knowledge gaps, methodological challenges, and research needs on vitamin D production, activation, metabolism, and status assessment across the life cycle. The two-day conference will open with a review of vitamin D production, bioavailability, metabolism, active forms, functions, and metabolic turnover. Vitamin D’s effects on health outcomes across the life cycle and measurement of status will also be critically evaluated. Other topics to be addressed include the impact of dietary intakes and sun exposure on blood levels of 25(OH)D and its relationship to vitamin D status. At the conference, invited experts will present information pertinent to these topics and goals. The findings of the AHRQ evidence-based review on vitamin D will also be presented. Each of the four sessions will include a panel of the presenters who will address questions relevant to the session topic and suggest future research needs. Attendees will have opportunities to engage in discussions with the panels. Each panel’s summary presentation will become part of the conference record and be used by organizers to compile conference proceedings and to inform NIH’s research agenda. This conference will be of interest to scientists and health professionals with a background and/or interest in vitamin D. Application has been made for Continuing Professional Education Units from the American Dietetic Association (ADA). Advance information about the conference and conference registration PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 materials are available on the conference Web site: https:// vitaminDandhealth.od.nih.gov. For additional assistance you may contact Jeanette Naiman at the American Institutes for Research: jnaiman@air.org or 301–592–8600. American Institutes for Research’s mailing address is 10720 Columbia Pike, Silver Spring, MD 20901. Please Note: The NIH has instituted security measures to ensure the safety of NIH employees and property. All visitors must be prepared to show a photo ID upon request. Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter NIH buildings. For more information about security measures at NIH, please visit the Web site at https://www.nih.gov/about/ visitorsecurity.htm. Dated: July 13, 2007. Raynard S. Kington, Deputy Director, National Institutes of Health. [FR Doc. E7–14209 Filed 7–23–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) Notice of consideration of proposed actions under the NIH Guidelines. ACTION: SUMMARY: Proposals to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi and conorii has been submitted to the NIH Office of Biotechnology Activities (OBA). The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines, these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. These proposals will be discussed at the September 17–19, 2007 RAC meeting. DATES: The public is encouraged to submit written comments on these proposed actions. Comments may be submitted to the OBA in paper or electronic form at the OBA mailing, fax, and e-mail addresses shown below. Comments submitted by September 6, E:\FR\FM\24JYN1.SGM 24JYN1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 141 / Tuesday, July 24, 2007 / Notices 2007 will be reproduced and distributed to the RAC for consideration at its September meeting. In addition, an opportunity for public comment will be provided at that meeting. All written comments received in response to this notice will be available for public inspection at the NIH OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 (telephone, 301–496–9838), weekdays between the hours of 8:30 a.m. and 5 p.m. FOR FURTHER INFORMATION CONTACT: Contact OBA by e-mail at oba@od.nih.gov, or telephone at 301– 496–9838, if you have questions, or require additional information about these proposed actions. Comments may be submitted to the same e-mail address or by fax at 301–496–9839 or sent by U.S. mail to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 20892. For additional information about the RAC meeting at which these proposed actions will be deliberated, please visit the NIH OBA Web site at: https:// www4.od.nih.gov/oba/. SUPPLEMENTARY INFORMATION: OBA has received information regarding proposed experiments, which, to proceed, would require Major Actions under Section III–A–1–a of the NIH Guidelines. Under this section, if the deliberate transfer of a drug resistance trait to micro-organisms could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture the experiment must be reviewed by the RAC. Dr. David Walker, Chairman, Pathology Department, University of Texas Medical Branch, proposes to introduce DNA constructs encoding resistance to the antibiotic chloramphenicol into Rickettsia conorii and Rickettsia typhi with the goal of developing genetic tools to study the biology of these organisms and in particular the genes associated with virulence. Dr. Abdu Azad, Professor of Microbiology, University of Maryland proposes a similar experiment in R. typhi. Dr. Walker’s ultimate goal is to develop a vaccine for Rickettsia prowazekii, a Select Agent that causes epidemic typhus. Rickettsiae are spread to humans by arthropods and human to human transmission does not occur directly. R. conorii causes Mediterranean Spotted Fever, a disease endemic to southern Europe and Africa. Clinically, it typically presents with high fever, flulike symptoms, headache and a maculopapular rash. The disease is generally mild but severe forms include major neurological manifestations and VerDate Aug<31>2005 17:50 Jul 23, 2007 Jkt 211001 multi-organ failure with a mortality rate estimated up to 2.5%. R. typhi is found in the United States and many other parts of the world, although it is relatively uncommon. The clinical presentation in humans includes fever, headache, other constitutional symptoms and, in up to 40% of adults, neurological symptoms. Although generally mild it has a 1–4% mortality rate. Current first-line treatment for R. typhi and R. conorii is doxycycline or chloramphenicol. Due to its safety profile, doxycycline is the preferred antibiotic but chloramphenicol is indicated in certain patients. Background information may be obtained by contacting NIH OBA via email at oba@od.nih.gov. Alternatively, information is available on the OBA Web site at https://www4.od.nih.gov/oba/ rac/latestnewsrac.htm. Dated: July 17, 2007. Amy P. Patterson, Director, Office of Biotechnology Activities, National Institutes of Health. [FR Doc. E7–14215 Filed 7–23–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2007–28745] Merchant Marine Personnel Advisory Committee Coast Guard, DHS. Notice of meetings. AGENCY: ACTION: SUMMARY: The Merchant Marine Personnel Advisory Committee (MERPAC) will meet in Easton, MD, to discuss various issues relating to the training and fitness of merchant marine personnel. MERPAC advises the Secretary of Homeland Security on matters relating to the training, qualifications, licensing, and certification of seamen serving in the U. S. merchant marine. Both meetings will be open to the public. DATES: MERPAC will meet on Tuesday, September 11, 2007, from 8:30 a.m. to 4:30 p.m., and on Wednesday, September 12, 2007, from 8:30 to 3:30 p.m. These meetings may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before August 28, 2007. Requests to have a copy of your material distributed to each member of the committee or subcommittee should reach the Coast Guard on or before August 28, 2007. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 40321 MERPAC will meet in the Classroom Building Auditorium of the Calhoon MEBA Engineering School, 27050 St. Michaels Road, Easton, MD 21601. Further directions regarding the location of the Calhoon MEBA Engineering School may be obtained by going to the following link: https:// www.mebaschool.org/directions? SESS=cfb48385dacc691717e1df9c 9655f593&time=1181575289. Send written material and requests to make oral presentations to Mark Gould, Commandant (CG–3PSO–1), U.S. Coast Guard Headquarters, 2100 Second Street SW., Washington, DC 20593–0001. This notice is available on the Internet at https://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Mark Gould, Assistant Executive Director, telephone 202–372–1409, fax 202–372–1926. SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92–463)]. ADDRESSES: Agendas of Meetings Agenda of Meeting on September 11, 2007. The full committee will meet to discuss the objectives for the meeting. The working groups addressing the following task statements may meet to deliberate: Task Statement 30, concerning ‘‘Utilizing Military Sea Service for STCW Certifications’’; Task Statement 55, concerning ‘‘Recommendations to Develop a Voluntary Training Program for Deck and Engine Department Entry Level Mariners on Domestic and Seagoing Vessels’’; Task Statement 58, concerning ‘‘Stakeholder Communications During MLD Program Restructuring and Centralization’’; Task Statement 61, concerning ‘‘Merchant Mariner Medical Waiver Evaluation Guidelines’’; and Task Statement 64, concerning ‘‘Recommendations on Areas in the STCW Convention and the STCW Code Identified for Comprehensive Review.’’ In addition, new working groups may be formed to address issues proposed by the Coast Guard, MERPAC members, or the public. All task statements may be viewed at the MERPAC Web site at https://www.uscg.mil/hq/g-m/advisory/ merpac/merpac.htm. At the end of the day, the working groups will make a report to the full committee on what has been accomplished in their meetings. No action will be taken on these reports on this date. Agenda of Meeting on September 12, 2007: The agenda comprises the following: E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40320-40321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14215]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Biotechnology Activities; Recombinant DNA Research: 
Proposed Actions Under the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines)

ACTION: Notice of consideration of proposed actions under the NIH 
Guidelines.

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

SUMMARY: Proposals to conduct research involving the deliberate 
transfer of a chloramphenicol resistance trait to Rickettsia typhi and 
conorii has been submitted to the NIH Office of Biotechnology 
Activities (OBA). The acquisition of this antibiotic resistance trait 
could possibly compromise the use of a class of antibiotics for the 
treatment of Rickettsia infections in humans. Under the NIH Guidelines, 
these experiments can proceed only after they are reviewed by the NIH 
Recombinant DNA Advisory Committee (RAC) and specifically approved by 
the NIH Director as Major Actions. These proposals will be discussed at 
the September 17-19, 2007 RAC meeting.

DATES: The public is encouraged to submit written comments on these 
proposed actions. Comments may be submitted to the OBA in paper or 
electronic form at the OBA mailing, fax, and e-mail addresses shown 
below. Comments submitted by September 6,

[[Page 40321]]

2007 will be reproduced and distributed to the RAC for consideration at 
its September meeting. In addition, an opportunity for public comment 
will be provided at that meeting. All written comments received in 
response to this notice will be available for public inspection at the 
NIH OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 
(telephone, 301-496-9838), weekdays between the hours of 8:30 a.m. and 
5 p.m.

FOR FURTHER INFORMATION CONTACT: Contact OBA by e-mail at 
oba@od.nih.gov, or telephone at 301-496-9838, if you have questions, or 
require additional information about these proposed actions. Comments 
may be submitted to the same e-mail address or by fax at 301-496-9839 
or sent by U.S. mail to the Office of Biotechnology Activities, 
National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 
7985, Bethesda, Maryland 20892. For additional information about the 
RAC meeting at which these proposed actions will be deliberated, please 
visit the NIH OBA Web site at: https://www4.od.nih.gov/oba/.

SUPPLEMENTARY INFORMATION: OBA has received information regarding 
proposed experiments, which, to proceed, would require Major Actions 
under Section III-A-1-a of the NIH Guidelines. Under this section, if 
the deliberate transfer of a drug resistance trait to micro-organisms 
could compromise the use of the drug to control disease in humans, 
veterinary medicine, or agriculture the experiment must be reviewed by 
the RAC. Dr. David Walker, Chairman, Pathology Department, University 
of Texas Medical Branch, proposes to introduce DNA constructs encoding 
resistance to the antibiotic chloramphenicol into Rickettsia conorii 
and Rickettsia typhi with the goal of developing genetic tools to study 
the biology of these organisms and in particular the genes associated 
with virulence. Dr. Abdu Azad, Professor of Microbiology, University of 
Maryland proposes a similar experiment in R. typhi. Dr. Walker's 
ultimate goal is to develop a vaccine for Rickettsia prowazekii, a 
Select Agent that causes epidemic typhus.
    Rickettsiae are spread to humans by arthropods and human to human 
transmission does not occur directly. R. conorii causes Mediterranean 
Spotted Fever, a disease endemic to southern Europe and Africa. 
Clinically, it typically presents with high fever, flu-like symptoms, 
headache and a maculopapular rash. The disease is generally mild but 
severe forms include major neurological manifestations and multi-organ 
failure with a mortality rate estimated up to 2.5%. R. typhi is found 
in the United States and many other parts of the world, although it is 
relatively uncommon. The clinical presentation in humans includes 
fever, headache, other constitutional symptoms and, in up to 40% of 
adults, neurological symptoms. Although generally mild it has a 1-4% 
mortality rate. Current first-line treatment for R. typhi and R. 
conorii is doxycycline or chloramphenicol. Due to its safety profile, 
doxycycline is the preferred antibiotic but chloramphenicol is 
indicated in certain patients. Background information may be obtained 
by contacting NIH OBA via e-mail at oba@od.nih.gov. Alternatively, 
information is available on the OBA Web site at https://www4.od.nih.gov/
oba/rac/latestnewsrac.htm.

    Dated: July 17, 2007.
Amy P. Patterson,
Director, Office of Biotechnology Activities, National Institutes of 
Health.
[FR Doc. E7-14215 Filed 7-23-07; 8:45 am]
BILLING CODE 4140-01-P

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