Quality System Regulation Educational Forum on Design Controls; Public Workshop; Amendment of Notice, 70873-70874 [E7-24144]

Download as PDF 70873 Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Notices One collection, entitled ‘‘Health and Diet Survey—General Topics,’’ tracks a broad range of consumer attitudes, awareness, knowledge, and self-reported behaviors related to key diet and health issues. The other collection, entitled ‘‘Health and Diet Survey—Dietary Guidelines Supplement,’’ will provide FDA with updated information about consumer attitudes, awareness, knowledge, and behavior regarding various elements of nutrition and physical activity based on the key recommendations of the Dietary Guidelines for Americans, which are jointly issued by the Department of Health and Human Services and Department of Agriculture every 5 years. The information to be collected with the Health and Diet Survey—General Topics will include: (1) Awareness of diet-disease relationships; (2) food and dietary supplement label use; (3) dietary practices including strategies to lose or maintain weight; and (4) awareness and knowledge of dietary fats. The information to be collected with the Health and Diet Survey—Dietary Guidelines Supplement will include: (1) Opinions about the nutrition information provided by the government; (2) awareness and familiarity with government nutrition programs and publications such as the Food Guide Pyramid and the Dietary Guidelines for Americans; (3) knowledge of the relationships between food choices, exercise habits, weight loss, and health; (4) choices surrounding exercise, calorie intake, saturated and trans fats, fruits and vegetables, whole grains, dairy, fish, meat, cholesterol, carbohydrates, salt, and sugar. The survey will also ask about use of Federal nutrition information, special diet, weight status, health status, and demographics. FDA and other Federal agencies will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy lifestyles. The information will also help FDA and other Federal agencies evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health. Description of Respondents: The respondents are adults, age 18 and older, drawn from the 50 states and the District of Columbia. Participation will be voluntary. In the Federal Register of May 25, 2007 (72 FR 29332), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Activity No. of Respondents General Topics: Pretest Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 27 1 27 0.25 6.75 10,000 1 10,000 0.02 200 General Topics: Survey 3,000 1 3,000 0.25 750 Dietary Guidelines Supplement: Screener 4,000 1 4,000 0.02 80 Dietary Guidelines Supplement: Survey 1,200 1 1,200 0.22 264 General Topics: Screener Total mstockstill on PROD1PC66 with NOTICES 1There 1,300.75 are no capital costs or operating and maintenance costs associated with this collection of information. FDA has based its estimate of the number of respondents and the burden hours per response on its experience with the Health and Diet Survey over the past 3 years. The agency will use a screener to select an eligible adult respondent in each household to participate in the survey. For the Health and Diet Survey—General Topics data collection activity a total of 3,000 adults in the 50 states and the District of Columbia will be interviewed by telephone. We estimate that it will take a respondent 1.2 minutes (0.02 hours) to complete the screening questions and 15 minutes (0.25 hours) to complete the entire survey. Prior to the administration of the survey, the agency plans to conduct a pretest to identify and resolve potential problems. The pretest will be conducted with 27 participants; we estimate that it will take a respondent 15 minutes (0.25 hours) to complete the pretest. For the Health and Diet Survey—Dietary VerDate Aug<31>2005 17:10 Dec 12, 2007 Jkt 214001 GuidelinesSupplement data collection activity a total of 1,200 adults in the 50 states and the District of Columbia will be interviewed by telephone. We estimate that it will take a respondent 1.2 minutes (0.02 hours) to complete the screening questions and 13.2 minutes (0.22 hours) to complete the entire survey. Target sample size of the combined data collection is 4,200 respondents who complete the survey. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–24123 Filed 12–12–07; 8:45 am] SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop entitled ‘‘Quality System Regulation Educational Forum on Design Controls.’’ This workshop was announced in the Federal Register of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the Location portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: David Arvelo, Food and Drug BILLING CODE 4160–01–S PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Food and Drug Administration Quality System Regulation Educational Forum on Design Controls; Public Workshop; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\13DEN1.SGM Notice. 13DEN1 70874 Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Notices Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253–4952, FAX: 214–253– 4970, e-mail: david.arvelo@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2007 (72 FR 57951), FDA announced that a public workshop entitled ‘‘Quality System Regulation Educational Forum on Design Controls’’ would be held on Friday, April 4, 2008. On page 57951, in the second column, the Location portion of the document is amended to read as follows: Location: The public workshop will be held at the Adam’s Mark Hotel Dallas, 400 North Olive St., Dallas, TX 75201, 214–922–8000. Directions to the facility and additional information are available at the FDA Medical Device Industry Coalition Web site at https:// www.fmdic.org/. Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–24144 Filed 12–12–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings mstockstill on PROD1PC66 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Operations and Technical Support at the NCI-Frederick. Date: January 7, 2008. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. Contact Person: Lalita D. Palekar, PhD. Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer VerDate Aug<31>2005 17:10 Dec 12, 2007 Jkt 214001 Institute, 6116 Executive Blvd., Bethesda, MD 20892–7405, 301–496–7575, palekarl@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee G–Education. Date: February 12–13, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. Contact Person: Sonya Roberson, PhD, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 8109, Bethesda, MD 20892, 301–594–1182, robersos@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, R25(E) Special Emphasis Panel (SEP). Date: February 12, 2008. Time: 5 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. Contact Person: Lynn M. Amende, PhD, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard Room 8105 Bethesda, MD 20892–8328, 301–451– 4759, amendel@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research, 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: December 4, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–6034 Filed 12–12–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public as indicated below, with attendance limited to space available. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering, NACBIB January 2008. Date: January 25, 2008. Open: 8:30 a.m. to 1 p.m. Agenda: Report from the Institute Director and other Institute staff and presentations of working group reports. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Closed: 1 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Anthony Demsey, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, 6701 Democracy Blvd., Room 241, Bethesda, MD 20892. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib1.nih.gov/about/NACBIB/ NACBIB.htm, where an agenda and any additional information for the meeting will be posted when available. Dated: December 5, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–6031 Filed 12–12–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute On Aging; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Notices]
[Pages 70873-70874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24144]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Quality System Regulation Educational Forum on Design Controls; 
Public Workshop; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of public workshop entitled ``Quality System 
Regulation Educational Forum on Design Controls.'' This workshop was 
announced in the Federal Register of October 11, 2007 (72 FR 57951). 
The amendment is made to reflect a change in the Location portion of 
the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: David Arvelo, Food and Drug

[[Page 70874]]

Administration, 4040 North Central Expressway, suite 900, Dallas, TX 
75204, 214-253-4952, FAX: 214-253-4970, e-mail: 
david.arvelo@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2007 
(72 FR 57951), FDA announced that a public workshop entitled ``Quality 
System Regulation Educational Forum on Design Controls'' would be held 
on Friday, April 4, 2008. On page 57951, in the second column, the 
Location portion of the document is amended to read as follows:
    Location: The public workshop will be held at the Adam's Mark Hotel 
Dallas, 400 North Olive St., Dallas, TX 75201, 214-922-8000. Directions 
to the facility and additional information are available at the FDA 
Medical Device Industry Coalition Web site at https://www.fmdic.org/.

    Dated: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24144 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S

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