Food Advisory Committee; Notice of Meeting, 41697-41698 [2014-16777]

Download as PDF Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices To ensure that such health communication messages have the highest potential to be received, understood, and are accepted by those for whom they are intended, FDA’s Center for Tobacco Products will conduct research and studies relating to the control and prevention of disease. In conducting such research, FDA will employ formative pretests. Formative pretests are conducted on a small scale, and their focus is on developing and assessing the likely effectiveness of communications with specific target audiences. This type of research involves (1) assessing audience knowledge, attitudes, behaviors, and other characteristics for the purpose of determining the need for and developing health messages, communication strategies, and public information programs; and (2) pretesting these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. Formative pretesting is a staple of best practices in communications research. Obtaining feedback from intended audiences during the development of messages and materials is crucial for the success of every communication program. The purpose of obtaining information from formative pretesting is that it allows FDA to improve materials and strategies while revisions are still affordable and possible. Formative pretesting can also avoid potentially expensive and dangerous unintended outcomes caused by audiences’ interpreting messages in a way that was not intended by the drafters. By maximizing the effectiveness of 41697 messages and strategies for reaching targeted audiences, the frequency with which tobacco communication messages need to be modified should be greatly reduced. The information collected will serve the primary purpose of providing FDA information about the perceived effectiveness of messages, advertisements, and materials in reaching and successfully communicating with their intended audiences. Quantitative testing messages and other materials with a sample of the target audience will allow FDA to refine messages, advertisements, and materials, including questionnaires or images, directed at consumers while they are still in the developmental stage. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Self-Administered Surveys ................................... 30,300 1 30,300 0.33 (20 minutes) .......... 9,999 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents to be included in each new survey will vary, depending on the nature of the material or message being tested and the target audience. Dated: July 14, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–16795 Filed 7–16–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Food Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. VerDate Mar<15>2010 17:31 Jul 16, 2014 Jkt 232001 Date and Time: The meeting will be held on September 29 and 30, 2014, from 8:30 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Karen Strambler, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–2589 or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). 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 at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 advisory committee information line to learn about possible modifications before coming to the meeting. If you are unable to join us in person, we encourage you to watch the Web cast. Visit the Food Advisory Committee Web site at https://www.fda.gov/ AdvisoryCommittees/ CommitteesMeetingMaterials/ FoodAdvisoryCommittee/default.htm. The link will become active shortly before the open session begins at 8:30 a.m. Agenda: The Food Advisory Committee will discuss risk ranking and risk prioritization approaches for specific regulatory purposes. The Committee will provide input to FDA in the development of the characteristics for data collections and risk ranking/risk prioritization models. These characteristics would be useful in framing the fundamental elements needed to design or evaluate FDA’s food and veterinary programs. 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 E:\FR\FM\17JYN1.SGM 17JYN1 pmangrum on DSK3VPTVN1PROD with NOTICES 41698 Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting 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 September 22, 2014. Oral presentations from the public will be scheduled between approximately 11 a.m. to 12 p.m. on September 30, 2014. Those individuals interested in making 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 September 12, 2014. 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 September 15, 2014. 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 Karen Strambler 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 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.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: July 10, 2014. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2014–16777 Filed 7–16–14; 8:45 am] BILLING CODE 4164–01–P VerDate Mar<15>2010 15:01 Jul 16, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0889] Site Tours Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science is announcing an invitation for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or currently regulated tobacco products (i.e., cigarettes, roll-your-own, and smokeless tobacco). These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP. DATES: Interested parties should submit either an electronic or written request for participation by September 15, 2014. The request should include a description of your facility, including as applicable, a list of all tobacco products processed and/or manufactured there. Please specify the physical address(es) of the site(s) for which you are submitting a request along with a proposed 1-day tour agenda. ADDRESSES: If your facility is interested in offering a site visit, you should submit a request to participate in the program either electronically to https:// www.regulations.gov or in writing to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Carolyn Dresler, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993– 0002, 240–402–4067, carolyn.dresler@ fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Control Act (Pub. L. 111–31) was signed into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. CTP’s Office of Science is continuing the Site Tours Program to provide its scientific and regulatory staff the opportunity to gain a better understanding of the tobacco industry and its operations, including tobacco product manufacturing and aspects of tobacco growing, processing, and storage that may affect the physical and chemical properties of tobacco. Although FDA generally does not regulate tobacco farms and tobacco warehouses, the Agency believes that gaining a better understanding of the operations performed at these facilities may be helpful. The goals of the Site Tours Program are to: (1) Provide CTP firsthand exposure to industry’s manufacturing processes; (2) learn about control measures used by tobacco product manufacturers to ensure product consistency; (3) understand the processing of different forms of tobacco and the manufacturing processes used for various types of tobacco products and their influences on product constituents; and (4) understand how growing conditions, curing, storage, and manufacturing processes might influence the levels of tobacco or tobacco smoke constituents. II. Description of Site Tours Program In the Site Tours Program, small groups of CTP staff plan to observe the operations of tobacco growers, tobacco warehouses, and tobacco product manufacturing facilities of cigarettes, roll-your-own, and smokeless tobacco companies, including the manufacturing of paper, filters, and pouch materials. Please note that the Site Tours Program is not intended to include official FDA inspections of facilities to determine compliance with the FD&C Act or for the purposes of developing Tobacco Product Manufacturing Practice regulations; rather, the program is meant to educate CTP staff and improve their understanding of the tobacco industry and its operations. III. Site Selection CTP plans to select one or more of each of the following types of facilities: A large cigarette manufacturing facility, a small cigarette manufacturing facility, a smokeless manufacturing facility, a burley tobacco farm, a flue-cured tobacco farm, a tobacco rolling paper facility, a tobacco warehouse and a tobacco processing facility. All travel expenses associated with the site tours E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41697-41698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Food Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory of 
the Food and Drug Administration (FDA). The meeting will be open to the 
public.
    Name of Committee: Food 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 September 29 and 30, 
2014, from 8:30 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Karen Strambler, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-2589 or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting. If you are unable to join us in person, we encourage you 
to watch the Web cast. Visit the Food Advisory Committee Web site at 
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/default.htm. The link will become active shortly 
before the open session begins at 8:30 a.m.
    Agenda: The Food Advisory Committee will discuss risk ranking and 
risk prioritization approaches for specific regulatory purposes. The 
Committee will provide input to FDA in the development of the 
characteristics for data collections and risk ranking/risk 
prioritization models. These characteristics would be useful in framing 
the fundamental elements needed to design or evaluate FDA's food and 
veterinary programs.
    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

[[Page 41698]]

available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
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 
September 22, 2014. Oral presentations from the public will be 
scheduled between approximately 11 a.m. to 12 p.m. on September 30, 
2014. Those individuals interested in making 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 
September 12, 2014. 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 September 15, 
2014.
    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 Karen Strambler 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: July 10, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-16777 Filed 7-16-14; 8:45 am]
BILLING CODE 4164-01-P

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