Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 65386-65387 [E8-26139]

Download as PDF 65386 Federal Register / Vol. 73, No. 213 / Monday, November 3, 2008 / Notices submitted to the agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The agency recommends that a request be submitted as an amendment in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the agency’s tracking databases enables the appropriate agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner. CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue; the nature of the issue (i.e., scientific, procedural, or both); possible solutions based on information in the administrative file; whether informal dispute resolution was sought prior to the formal appeal; whether advisory committee review is sought; and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information. Based on FDA’s experience with dispute resolution, the agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal. Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute. Burden Estimate: Provided in table 1 of this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 13 sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately 1 respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 22 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with the guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 184 hours will be spent per year by respondents requesting formal dispute resolution under the guidance. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Requests for Formal Dispute Resolution No. of Respondents No. of Responses per Respondent Total Annual Responses Hours Per Response Total Hours CDER 13 1.7 22 8 176 CBER 1 1 1 8 8 Total 1 There 184 are no capital costs or operating and maintenance costs associated with this collection of information. sroberts on PROD1PC70 with NOTICES 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: October 23, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–26095 Filed 10–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee VerDate Aug<31>2005 16:58 Oct 31, 2008 Jkt 217001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 73, No. 213 / Monday, November 3, 2008 / Notices of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 20, 2008, from 1 p.m. to approximately 4 p.m. Location: National Institutes of Health, Building 29B, Conference Room C. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at http://www.nih.gov/about/visitor/ index.htm. Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver’s license, passport, green card, etc. Detailed information about security procedures is located at http://www.nih.gov/about/ visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike. Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On November 20, 2008, the Committee will meet in open session to hear updates of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. VerDate Aug<31>2005 16:58 Oct 31, 2008 Jkt 217001 If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: On November 20, 2008, from 1 p.m. to approximately 3:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 13, 2008. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 5, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 6, 2008. Closed Committee Deliberations: On November 20, 2008, from approximately 3:30 p.m. to 4 p.m. the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the report of the intramural research program and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 65387 FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Dated: October 21, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–26139 Filed 10–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Follow-Up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Follow-up of Kidney Cancer Patients from the Central European Multicenter CaseControl Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this questionnaire is to obtain information on the 5-year survival status of kidney cancer patients that were enrolled in a Central European CaseControl Study of Kidney Cancer that was conducted between 2001–2004. The aim is to assess survival, the prevalence of recurrent disease and progression, and to investigate patient, tumor and genetic determinants of survival among cases. The questionnaire will collect information on patient related factors, tumor related factors not collected during the initial study, and the type of treatment(s) received since the patients were last contacted for the case-control study. This questionnaire adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a–1) and section 413 (42 U.S.C. 285a–2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and E:\FR\FM\03NON1.SGM 03NON1

Agencies

[Federal Register Volume 73, Number 213 (Monday, November 3, 2008)]
[Notices]
[Pages 65386-65387]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee

[[Page 65387]]

of the Food and Drug Administration (FDA). At least one portion of the 
meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 20, 2008, from 
1 p.m. to approximately 4 p.m.
    Location: National Institutes of Health, Building 29B, Conference 
Room C. This meeting will be held by teleconference. The public is 
welcome to attend the meeting at the specified location where a 
speakerphone will be provided. Public participation in the meeting is 
limited to the use of the speakerphone in the conference room. 
Important information about transportation and directions to the NIH 
campus, parking, and security procedures is available on the Internet 
at http://www.nih.gov/about/visitor/index.htm. Visitors must show two 
forms of identification, one of which must be a government-issued photo 
identification such as a Federal employee badge, driver's license, 
passport, green card, etc. Detailed information about security 
procedures is located at http://www.nih.gov/about/visitorsecurity.htm. 
Due to the limited available parking, visitors are encouraged to use 
public transportation.
    Contact Person: Christine Walsh or Denise Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike. Rockville, MD 20852, 301-827-0314, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On November 20, 2008, the Committee will meet in open 
session to hear updates of the research program in the Laboratory of 
DNA Viruses, Division of Viral Products, Center for Biologics 
Evaluation and Research, FDA.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: On November 20, 2008, from 1 p.m. to approximately 3:30 
p.m., the meeting is open to the public. Interested persons may present 
data, information, or views, orally or in writing, on issues pending 
before the committee. Written submissions may be made to the contact 
person on or before November 13, 2008. Oral presentations from the 
public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. 
Those desiring to make formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before November 5, 2008. 
Time allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by November 6, 2008.
    Closed Committee Deliberations: On November 20, 2008, from 
approximately 3:30 p.m. to 4 p.m. the meeting will be closed to permit 
discussion where disclosure would constitute a clearly unwarranted 
invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will 
discuss the report of the intramural research program and make 
recommendations regarding personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Christine Walsh or 
Denise Royster at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.

    Dated: October 21, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26139 Filed 10-31-08; 8:45 am]
BILLING CODE 4160-01-S