Advisory Commission on Childhood Vaccines; Notice of Meeting, 29138-29139 [E8-11237]

Download as PDF 29138 Federal Register / Vol. 73, No. 98 / Tuesday, May 20, 2008 / Notices includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.regulations.gov. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidance represents the agency’s current thinking on ‘‘Plasmodium species antigen detection assays.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. jlentini on PROD1PC65 with NOTICES guidance document will serve as the special control for Plasmodium species antigen detection assays. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. V. Comments III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240– 276–3151 to receive a hard copy. Please use the document number 1646 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page VerDate Aug<31>2005 18:23 May 19, 2008 Jkt 214001 IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or submit two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: April 30, 3008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8–11261 Filed 5–19–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Commission on Childhood Vaccines (ACCV). Date and Time: June 5, 2008, 12 p.m. to 5 p.m. EDT. June 6, 2008, 9 a.m. to 12:30 p.m. EDT. Place: Parklawn Building (and via audio conference call), Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857. The ACCV will meet on Thursday, June 5 from 1 p.m. to 5 p.m. (EDT) and Friday, June 6 from 9 a.m. to 12:30 p.m. (EDT). The public can join the meeting via audio conference call by dialing 1–888–593–8429 on June 5 & 6 and providing the following information: Leader’s Name: Dr. Geoffrey Evans. Password: ACCV. Agenda: The agenda items for the June meeting will include, but are not limited to: updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics Evaluation and Research (Food and Drug Administration). Agenda items are subject to change as priorities dictate. Public Comments: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Michelle Herzog, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C–26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: mherzog@hrsa.gov. Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. For Further Information Contact: Anyone requiring information regarding the ACCV should contact Michelle Herzog, DVIC, HSB, HRSA, Room 11C–26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443– 6593 or e-mail: mherzog@hrsa.gov. E:\FR\FM\20MYN1.SGM 20MYN1 Federal Register / Vol. 73, No. 98 / Tuesday, May 20, 2008 / Notices Dated: May 14, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8–11237 Filed 5–19–08; 8:45 am] BILLING CODE 4165–15–P Room A322, Research Triangle Park, NC 27709. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Barbara Shane (telephone: 919–541– 4253 or e-mail: shane@niehs.nih.gov). National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Document for Styrene; Request for Comments on the Draft Background Document for Styrene; Announcement of the Styrene Expert Panel Meeting FOR FURTHER INFORMATION CONTACT: Telephone Call-in Line DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors: Amended Notice National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health. AGENCY: Availability of a Public Telephone Call-In Line. ACTION: SUMMARY: This notice announces the availability of a public telephone call-in line for the June 11–12, 2008 meeting of the NTP Board of Scientific Counselors. The meeting will be held at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 and videocast through the Internet at http://www.niehs.nih.gov/ news/video/live. Information regarding the meeting was announced in the Federal Register (73FR20289) published on April 15, 2008. The guidelines published in the April 15 Federal Register notice for submitting written public comments or making an oral presentation at the meeting still apply. In response to the public interest in the peer review of the Draft NTP Brief on Bisphenol A, the NTP will provide a telephone call-in line for public comments. The line will be open from 8:30 a.m. until 3 p.m. on June 11, although public comments will be received only during the formal public comment period on the draft brief. The exact time for the presentation of public comments is not set, but will follow the overview presentation on the draft brief and the talk on biomonitoring of bisphenol A exposures (the preliminary agenda is available at (http:// ntp.niehs.nih.gov/go/165) or by contacting Dr. Barbara Shane, see FOR FURTHER INFORMATION CONTACT below). Public comments on all agenda topics and any other correspondence should be submitted to Dr. Barbara Shane, Executive Secretary for the NTP BSC, NTP Office of Liaison, Policy and Review, NIEHS, P.O. Box 12233, MD A3–01, Research Triangle Park, NC 27709; telephone: 919–541– 4253; fax: 919–541–0295; or e-mail: shane@niehs.nih.gov. Courier address: NIEHS, 111 T.W. Alexander Drive, jlentini on PROD1PC65 with NOTICES ADDRESSES: VerDate Aug<31>2005 18:23 May 19, 2008 Jkt 214001 29139 The following information is required for telephone access: • USA Toll Free Number: 877–915– 2768. • Passcode: NTP. • Leader Name: Barbara Shane. The NTP has reserved 50 telephone lines for this call and access availability will be on a first come first served basis. Telephone comments should not exceed three minutes in length and each organization is allowed only one oral slot (in person at the meeting or by telephone) per agenda topic. Calls will be taken as time permits and at the discretion of the BSC chairperson. Every effort will be made to accommodate callers, but the total time allotted for comments and the time allotted per speaker via the telephone will depend on how many people register online to speak. Registration to present oral public comments or to submit written comments can be completed online at the BSC meeting site (http:// ntp.niehs.nih.gov/go/165). Details about the meeting, Internet access, and telephone call-in are also available at this site. The public telephone call-in is a new remote access option for the BSC, thus its technical quality cannot be guaranteed. Persons who register online to make oral comments by telephone are asked, if possible, to send a copy of their statement to the Executive Secretary for the NTP BSC (see ADDRESSES above) by June 4, 2008, to enable review by the NTP BSC prior to the meeting. Written statements can supplement and may expand the oral presentation. Dated: May 8, 2008. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E8–11206 Filed 5–19–08; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). ACTION: Availability of Background Documents; Request for Comments; and Announcement of a Meeting. AGENCY: SUMMARY: The NTP announces the availability of the draft background document for styrene on May 22, 2008, on the RoC Web site (http:// ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for styrene. The expert panel will meet on July 21– 22, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 to peer review the draft background document for styrene and, once completed, make a recommendation regarding the listing status for styrene (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background document and the expert-panel peer review report on the RoC Web site. DATES: The expert panel meeting for styrene will be held on July 21–22, 2008. The draft background document for styrene will be available for public comment on May 22, 2008. The deadline to submit written comments is July 07, 2008, for pre-registration to attend the meeting is July 14, 2008, and for pre-registration to provide oral comments at the meeting is July 14, 2008. ADDRESSES: The RoC expert panel meeting on styrene will be held at Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709. Access to on-line registration and materials for the meeting are available on the RoC Web site (http:// ntp.niehs.nih.gov/go/29679). Comments E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 73, Number 98 (Tuesday, May 20, 2008)]
[Notices]
[Pages 29138-29139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:

    Name: Advisory Commission on Childhood Vaccines (ACCV).
    Date and Time: June 5, 2008, 12 p.m. to 5 p.m. EDT. June 6, 
2008, 9 a.m. to 12:30 p.m. EDT.
    Place: Parklawn Building (and via audio conference call), 
Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.
    The ACCV will meet on Thursday, June 5 from 1 p.m. to 5 p.m. 
(EDT) and Friday, June 6 from 9 a.m. to 12:30 p.m. (EDT). The public 
can join the meeting via audio conference call by dialing 1-888-593-
8429 on June 5 & 6 and providing the following information:
    Leader's Name: Dr. Geoffrey Evans.
    Password: ACCV.
    Agenda: The agenda items for the June meeting will include, but 
are not limited to: updates from the Division of Vaccine Injury 
Compensation (DVIC), Department of Justice, National Vaccine Program 
Office, Immunization Safety Office (Centers for Disease Control and 
Prevention), National Institute of Allergy and Infectious Diseases 
(National Institutes of Health), and Center for Biologics Evaluation 
and Research (Food and Drug Administration). Agenda items are 
subject to change as priorities dictate.
    Public Comments: Persons interested in providing an oral 
presentation should submit a written request, along with a copy of 
their presentation to: Michelle Herzog, DVIC, Healthcare Systems 
Bureau (HSB), Health Resources and Services Administration (HRSA), 
Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: 
mherzog@hrsa.gov. Requests should contain the name, address, 
telephone number, and any business or professional affiliation of 
the person desiring to make an oral presentation. Groups having 
similar interests are requested to combine their comments and 
present them through a single representative. The allocation of time 
may be adjusted to accommodate the level of expressed interest. DVIC 
will notify each presenter by mail or telephone of their assigned 
presentation time. Persons who do not file an advance request for a 
presentation, but desire to make an oral statement, may announce it 
at the time of the comment period. These persons will be allocated 
time as it permits.
    For Further Information Contact: Anyone requiring information 
regarding the ACCV should contact Michelle Herzog, DVIC, HSB, HRSA, 
Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 
443-6593 or e-mail: mherzog@hrsa.gov.


[[Page 29139]]


    Dated: May 14, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-11237 Filed 5-19-08; 8:45 am]
BILLING CODE 4165-15-P