Pediatric Advisory Committee; Notice of Meeting, 58310-58311 [E7-20302]

Download as PDF 58310 Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices • To better understand consumers’ attitudes and emotions in response to topics and concepts, and • To further explore findings obtained from quantitative studies. FDA will use focus group findings to test and refine their ideas, but will 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden for completing the forms for this collection of information as follows: generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. In the Federal Register of March 27, 2007 (72 FR 14279), FDA published a TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 FDA Center No. of Focus Groups per Study Subject No. of Focus Groups Sessions Conducted Annually No. of Participants per Group Hours of Duration for Each Group (Includes Screening) 1 5 9 1.58 71 10 200 9 1.58 2,844 Total Hours Center for Biologics Evaluation and Research May use focus groups when appropriate Center for Drug Evaluation and Research Varies (e.g., direct-to-consumer Rx drug promotion, physician labeling of Rx drugs, medication guides, over-the-counter drug labeling, risk communication) Center for Devices and Radiological Health Varies (e.g., FDA Seal of Approval, patient labeling, tampons, online sales of medical products, latex gloves) 4 16 9 2.08 300 Center for Food Safety and Applied Nutrition Varies (e.g., food safety, nutrition, dietary supplements, and consumer education) 8 40 9 1.58 569 Center for Veterinary Medicine Varies (e.g., animal nutrition, supplements, labeling of animal Rx) 5 25 9 2.08 468 28 286 9 1.78 4,252 Total 1There are no capital costs or operating and maintenance costs associated with this collection of information. Annually, FDA projects about 28 focus group studies using 186 focus groups lasting an average of 1.78 hours each. FDA has allowed burden for unplanned focus groups to be completed so as not to restrict the agency’s ability to gather information on public sentiment for its proposals in its regulatory as well as other programs. Dated: October 9, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–20291 Filed 10–12–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sroberts on PROD1PC70 with NOTICES Pediatric 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 21:55 Oct 12, 2007 Jkt 214001 of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services, when that research is also regulated by FDA. Date and Time: The meeting will be held on Tuesday, November 27, 2007, from 8 a.m. to 5:30 p.m. and Wednesday, November 28, 2007, from 8 a.m. to 6 p.m. Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. ˜ Contact Person: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner (HF–33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B–08), PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Rockville, MD 20857, 301–827–3340, e˜ mail:Carlos.Pena@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 8732310001. 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 27, 2007, in response to the Pediatric Advisory Committee’s 2005 request for specific updates after 2 additional years of influenza seasons, the committee will receive information on adverse event reports, focusing on neuropsychiatric and behavioral events, for Tamiflu (OSELTAMIVIR). On November 28, 2007, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in Section 17 of E:\FR\FM\15OCN1.SGM 15OCN1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for Serevent (SALMETEROL), Provigil (MODAFINIL), Azopt (BRINZOLAMIDE), Bextaxon (LEVOBETAXOLOL), Emtrivia (EMTRICITABINE), and Gleevec (IMATINAB MESYLATE). The Pediatric Advisory Committee will also hear about and discuss the Pediatric Initiatives between FDA and the European Medicines Agency. 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 https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Procedure: 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 5, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2: p.m. on November 27, 2007 and 11 a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on November 28, 2007. 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 October 26, 2007. 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 October 29, 2007. 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 Dr. Carlos VerDate Aug<31>2005 21:55 Oct 12, 2007 Jkt 214001 ˜ Pena 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 athttps://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 8, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20302 Filed 10–12–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services , when that research is also regulated by FDA. Date and Time: The meeting will be held on Thursday, November 29, 2007, from 8 a.m. to 4 p.m. Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. ˜ Contact Person: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner (HF–33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B–08), Rockville, MD 20857, 301–827–3340, e˜ mail: Carlos.Pena@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 58311 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: The Pediatric Advisory Committee will hear and discuss issues related to FDA’s draft guidance for Industry entitled ‘‘Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling,’’ that published in the Federal Register of Tuesday, February 8, 2005 (70 FR 6697). As part of the review and consideration of public comments received by FDA in response to this draft guidance, the Pediatric Advisory Committee will hear and discuss information on: Labeling of drugs for use by lactating women; breastfeeding physiology, benefits, and current research; the physiology and pharmacology of drug transfer into breast milk; and ethical issues related to studying breastfeeding mother/infant pairs. 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 will be available at https://www.fda.gov/ ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Procedure: 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 5, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 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 October 26, 2007. 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 E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58310-58311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20302]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pediatric Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues. The committee 
also advises and makes recommendations to the Secretary of Health and 
Human Services under 45 CFR 46.407 on research involving children as 
subjects that is conducted or supported by the Department of Health and 
Human Services, when that research is also regulated by FDA.
    Date and Time: The meeting will be held on Tuesday, November 27, 
2007, from 8 a.m. to 5:30 p.m. and Wednesday, November 28, 2007, from 8 
a.m. to 6 p.m.
    Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Carlos Pe[ntilde]a, Office of Science and Health 
Coordination, Office of the Commissioner (HF-33), Food and Drug 
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), 
Rockville, MD 20857, 301-827-3340, e-
mail:Carlos.Pe[ntilde]a@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 8732310001. 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 27, 2007, in response to the Pediatric Advisory 
Committee's 2005 request for specific updates after 2 additional years 
of influenza seasons, the committee will receive information on adverse 
event reports, focusing on neuropsychiatric and behavioral events, for 
Tamiflu (OSELTAMIVIR). On November 28, 2007, the Pediatric Advisory 
Committee will hear and discuss reports by the agency, as mandated in 
Section 17 of

[[Page 58311]]

the Best Pharmaceuticals for Children Act (BPCA), on adverse event 
reports for Serevent (SALMETEROL), Provigil (MODAFINIL), Azopt 
(BRINZOLAMIDE), Bextaxon (LEVOBETAXOLOL), Emtrivia (EMTRICITABINE), and 
Gleevec (IMATINAB MESYLATE). The Pediatric Advisory Committee will also 
hear about and discuss the Pediatric Initiatives between FDA and the 
European Medicines Agency.
    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 https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and scroll down to the appropriate advisory committee 
link.
    Procedure: 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 5, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 2: p.m. on November 27, 2007 and 11 
a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on November 28, 2007. 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 October 26, 2007. 
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 October 29, 2007.
    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 Dr. Carlos 
Pe[ntilde]a 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 athttps://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20302 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.