Vision 2006-A Conversation With the American Public; Notice of Public Meetings on Specific Food and Drug Administration Issues; Request for Comments, 48160-48162 [05-16281]

Download as PDF 48160 Federal Register / Vol. 70, No. 157 / Tuesday, August 16, 2005 / Notices current ICH guidances. FDA agrees with these comments and the ‘‘Not Serious’’ and ‘‘No Harm’’ checkboxes do not appear on the final Form FDA 3500 and Form FDA 3500A. Another proposed checkbox was ‘‘Important Medical Events’’. This checkbox has been revised on the final Form FDA 3500 and Form FDA 3500A to ‘‘Other Serious (Important Medical Events)’’. This new terminology is consistent with the definition of ‘‘Serious’’ in 21 CFR 310.305, 312.32, 314.80, and 600.80 as well as ICH E2A guidelines. In addition, the outcome ‘‘Required Intervention to Prevent Permanent Impairment/ Damage’’ has been revised, adding ‘‘(devices)’’ at the end of the term. Additional detail has been provided in the revised instructions to provide more clarity for the use of section B.2 of both forms. In section B.5 of both forms, the proposed checkboxes ‘‘Product Used During Pregnancy’’ and ‘‘Product Used During Breast Feeding’’ produced concern as these new data fields introduce divergence from ICH standards and appear to duplicate information that is usually provided in the narrative section and in coded adverse event terms. FDA agrees and has not included these checkboxes in the final forms. As a result, the term ‘‘Pregnancy’’ has been returned to the examples in section B.7 (Other Relevant History) on both Form FDA 3500 and Form FDA 3500A. A few comments noted the removal of the term ‘‘if known’’ from several fields of the forms and questioned this action as a new requirement for these data. The final forms do not contain the term ‘‘if known’’ in any of the fields for reasons of form consistency. This should not be interpreted as a new requirement. If information is not known for any of the fields, they should be left blank. This is reflected in the revised instructions. Several comments questioned the addition of the Unique Identifier Number (Unique ID) to proposed section D.9 of both forms. Unique ID is required under § 1271.350 for reporting of adverse events for HCT/Ps. One comment recommended the addition of ‘‘Solicited’’ and ‘‘Spontaneous’’ checkboxes to Form FDA 3500A. FDA has not accepted this recommendation. As described in an August 1997 guidance for industry entitled ‘‘Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report,’’ information concerning potential adverse experiences derived during planned contacts and active solicitation of information from patients should be VerDate jul<14>2003 18:02 Aug 15, 2005 Jkt 205001 handled as safety information obtained from a postmarketing study. Section G of the previous and revised Form FDA 3500A contains a checkbox for ‘‘Study’’ which captures such information. One comment requested that FDA include information on drug name, dose, frequency, route, dates of diagnosis for use, and event abated/ reappeared after reintroduction on one line of Form FDA 3500 and Form FDA 3500A. FDA disagrees since these changes would decrease form clarity and would require costly and unnecessary computer and process revisions. One comment noted that the MedWatch program needs to do the following: (1) Enhance the quality, utility, and clarity of information to be collected; (2) data entry accuracy needs to be improved; and (3) the public version of the adverse events database needs to be posted in a timely manner, and FDA needs to vigorously enforce mandatory reporting requirements. FDA acknowledges these comments regarding FDA programs and processes. However, the comment did not suggest specific changes to Form FDA 3500 or Form FDA 3500A . In the final versions of Form FDA 3500 and Form FDA 3500A, there are some differences. FDA proposed adding two checkboxes to section B.1: ‘‘Product Use Error’’ and ‘‘Product Switch’’. Since there is currently no requirement to report medication, device, or other regulated product errors, these boxes do not appear on the final version of Form FDA 3500A . However, ‘‘Product Use Error’’ will be included on the voluntary Form FDA 3500, as the agency has become aware that voluntary reporters who wish to submit medication and other product use errors to FDA are not certain that Form FDA 3500 can be used for this purpose. FDA encourages voluntary reporting of product use errors. The ‘‘Product Switch’’ checkbox does not appear on the final Form FDA 3500A , however, a revised checkbox ‘‘Problem with different manufacturer of same medicine,’’ does appear on Form FDA 3500 to enable voluntary reporters to more clearly submit reports directly to FDA that involve adverse events or product problems related to brand-togeneric, generic-to-brand, one generic to another generic, or other therapy changes relating to the same active ingredient produced by different manufacturers. FDA proposed reformatting changes in sections A and D of both forms to conserve space on the forms. These changes do not appear on the final Form FDA 3500A; however, section D PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 (Suspect Product(s)) of revised Form FDA 3500 is modified. FDA believes the collection of data in specific boxes for dose/amount, frequency, and route increases clarity and enhances the likelihood that these data would be obtained from consumers and healthcare professionals who voluntarily submit reports directly to FDA. Several comments were received on new section C (Product Availability). Pharmaceutical manufacturers expressed concern that the practice of obtaining, storing, and analyzing returned products would significantly impact their working practice and goes beyond current regulations and guidances. FDA agrees with these comments and the ‘‘Product Availability’’ question has been returned to the ‘‘Suspect Medical Device’’ section of Form FDA 3500A . However, the revised voluntary Form FDA 3500 contains the new section C, to enable FDA to collect such information particularly for products that currently do not have mandatory adverse event reporting requirements, such as special nutritional products and cosmetics. Dated: August 9, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–16141 Filed 8–15–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0218] Vision 2006—A Conversation With the American Public; Notice of Public Meetings on Specific Food and Drug Administration Issues; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of meetings; request for comments. ACTION: SUMMARY: The Food and Drug Administration (FDA) is announcing a series of public meetings entitled ‘‘Vision 2006—A Conversation With the American Public,’’ in three cities. This forum will be an open format in which consumers can interact directly with the agency’s leadership to discuss what is on the public’s mind. It will also be an opportunity for the agency to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific E:\FR\FM\16AUN1.SGM 16AUN1 Federal Register / Vol. 70, No. 157 / Tuesday, August 16, 2005 / Notices issues. We may use the public input we receive to evaluate and to propose modifications, if necessary, to our programs and activities. DATES: See table 1, section III, of the SUPPLEMENTARY INFORMATION section of this document for meeting dates and times. See section IV of this document for information on how to register, to speak at, or to attend a meeting. Written or electronic comments must be received by November 30, 2005. ADDRESSES: See table 1, section III, of the SUPPLEMENTARY INFORMATION section of this document for meeting locations. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For information about this document: Philip L. Chao, Food and Drug Administration (HF–23), 5600 Fishers Lane, Rockville, MD 20857, 301–827–0587, FAX: 301–827– 4774, e-mail: philip.chao@fda.hhs.gov. For information regarding registration: Isabelle Howes, Graduate School, U.S. Department of Agriculture, 490 L’Enfant Plaza, Promenade Level, suite 710, Washington, DC 20024, 202–314– 4713, FAX: 202–479–6801, e-mail: Isabelle_Howes@grad.usda.gov. SUPPLEMENTARY INFORMATION: I. Why Do We Want to Hold Public Meetings? New medical products have played a critical role in improving the lives of millions of Americans, providing muchneeded treatments and cures for a wide range of illnesses. New advances in food technology and nutrition have enabled consumers to improve their health and well-being in countless ways. As we move forward in the 21st century, Americans are rightly concerned that advances in science should continue to translate into better products and technologies that can benefit their health. FDA lies at a critical juncture to enable these kinds of advances in science, technology, and health. The agency is responsible for protecting and promoting the public health by ensuring the safety and effectiveness of most human and animal drugs; biological products such as vaccines, cellular therapies, and blood; medical devices; VerDate jul<14>2003 18:02 Aug 15, 2005 Jkt 205001 tissues, and radiation-emitting products such as x-ray machines. We are also responsible for ensuring the safety and wholesomeness of food (including animal feed and dietary supplements) and cosmetics. Many Americans are rightly interested in FDA’s programs, and the steps that the agency is taking to ensure that the promise of better science translates into longer lives with fewer problems from today’s diseases. Consumers also want the opportunity to participate, in a meaningful way, in our work, whether we are discussing a complex scientific issue, proposing a regulation to address a particular problem, or implementing a new law. We are holding these public meetings to help enhance this dialogue. This series of meetings will be an open forum in which consumers can interact directly with the agency’s top leadership, including its leading scientists, to discuss what is on the public’s mind. We already provide similar opportunities for the public to engage in the agency’s decisionmaking processes. We encourage people to take advantage of these regular opportunities to provide the agency with critical input into its programs. For example, the agency hosts frequent public meetings to discuss specific topics, reserves time during advisory committee meetings for public input, and invites the public to submit written or electronic comments on our rules. In 2004, we received more than 140,000 comments (including form letters) on rules, notices, and other matters. But the series of public meetings being announced in this document is a unique gathering of all of the agency’s top leadership, including FDA Commissioner of Food and Drugs Lester Crawford, to provide direct feedback in an open forum on a broad range of issues of interest to the public. Through the public meetings we are announcing in this document, we are also offering an opportunity for the public to hear more about, and to give us input on, specific programs or initiatives that we are currently pursuing to better protect and advance the public health. Public input will help us shape the agency’s agenda for 2006 and beyond, as we commence our second century of serving the American public. Among some of the topics that we hope to discuss at the meetings are new opportunities to advance the safe use of medical products, increase the public health benefits of direct-toconsumer advertising, guarantee the safety and reliability of dietary supplements, and improve the science of drug development by lowering the cost of new medical products and PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 48161 speeding access to better medical technologies through the agency’s ‘‘Critical Path’’ initiative. We also hope to discuss our continuing efforts to increase public understanding of, and involvement in, the agency’s scientific and regulatory processes—for example, through our advisory committee process and through improved, direct communication with consumers. Through this open dialogue, the agency’s leadership hopes to gain valuable insight from those who benefit from its regulatory efforts. FDA appreciates all of the consumer interest in its activities, and the agency’s programs have benefited greatly from the feedback FDA receives from its many constituencies. To increase the transparency of our decisionmaking process, we are developing new, and expanding existing, communications channels to provide targeted information about new products to the public. We believe patients, healthcare professionals, and consumers will find the information useful in their individual treatment decisions. In an era when more and more of the products that people use are personalized to their individual needs, especially medical products and dietary choices, communicating the unique risks and benefits of individual products, and matching them to patients’ individual needs, becomes paramount. We want to ensure the information we provide and new efforts we are undertaking provide maximum value to consumers. Among the many questions we would like the public to consider are the following: • What information do you expect to receive from FDA regarding the benefits and risks of new food and medical products? • Where do you currently get information about these products, and how beneficial is this information in helping to inform the decisions you make? • What additional information, if any, do you believe should be provided to enable you to discuss with your physician or other health care provider the benefits and risks of products for a health condition you have or think you might have? • What additional steps can FDA take to improve its communication with consumers and build on your confidence in its activities and its mission? II. How Should You Send Comments on the Issues? If you would like to submit comments on any of the issues discussed in this document, please send your comments E:\FR\FM\16AUN1.SGM 16AUN1 48162 Federal Register / Vol. 70, No. 157 / Tuesday, August 16, 2005 / Notices to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two paper copies of any written comments, except that individuals may submit one paper copy. Comments should 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. To ensure consideration of your comments, we must receive any written or electronic comments by November 30, 2005. III. Where and When Will the Meetings Occur? We will hold public meetings in three cities to discuss the issues described earlier in this document. The meetings are scheduled from 10 a.m. to 4 p.m. The meeting dates, times, and locations are as follows: TABLE 1.—MEETING DATES, TIMES, AND LOCATIONS Location Meeting Site Address Meeting Date and Time Boston, MA Boston Marriott Cambridge, 2 Cambridge Center (Broadway and 3d St.), Cambridge, MA 02142 November 2, 2005, 10 a.m. to 4 p.m. Miami, FL Intercontinental West Miami, 2505 Northwest 87th Ave., Miami, FL 33172 September 13, 2005, 10 a.m. to 4 p.m. Phoenix, AZ Phoenix Airport Marriott, 1101 North 44th St., Phoenix, AZ 85008 November 30, 2005, 10 a.m. to 4 p.m. IV. Do You Have to Register to Make a Presentation at or to Attend a Meeting? If you wish to make a presentation at or to attend any meeting, please register online at https://www.grad.usda.gov/ vision at least 5 business days before the appropriate meeting date. The online registration form will instruct you as to the information you should provide (such as name, address, telephone number, electronic mail address, topic(s) of interest, whether you wish to make a presentation, and which meeting you wish to attend). We also will accept walk-in registrations on the meeting dates. However, space is limited, and we will close registration at each site when maximum seating capacity for that site is reached (approximately 150 people per location). We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations will depend on the number of people who wish to speak on a given topic, and the meeting schedule at each location. Similarly, the time allotted to each topic may vary depending on the expressed interests of persons registering for a particular meeting. To obtain updates on the meetings, please visit https:// www.fda.gov/oc/initiatives/ vision2006.html. Additionally, regardless of whether you wish to make a presentation or simply attend a meeting, if you need any special accommodations (such as wheelchair access or a sign language interpreter), please notify Isabelle Howes (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. V. Will Meeting Transcripts Be Available? We will prepare transcripts of each meeting. You may request a copy of a meeting transcript by writing to our Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857. We anticipate that transcripts will be available approximately 30 business days after the public meetings at a cost of 10 cents per page. The transcripts will also be available for public examination at the Division of Dockets Management (HFA– 305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 11, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–16281 Filed 8–15–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)–443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program Administrative Requirements (Regulations and Policy) (OMB No. 0915–0047)—Extension The regulations for the Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program contain a number of reporting and recordkeeping requirements for schools and loan applicants. The requirements are essential for assuring that borrowers are aware of rights and responsibilities that schools know the history and status of each loan account that schools pursue aggressive collection efforts to reduce default rates, and that they maintain adequate records for audit and assessment purposes. Schools are free to use improved information technology to manage the information required by the regulations. The burden estimates are as follows: RECORDKEEPING REQUIREMENTS Regulatory/section requirements Number of recordkeepers HPSL Program: 57.206(b)(2), Documentation of Cost of Attendance ..................................................... VerDate jul<14>2003 18:02 Aug 15, 2005 Jkt 205001 PO 00000 Hours per year 547 Frm 00064 Fmt 4703 Sfmt 4703 Total burden hours 1.17 E:\FR\FM\16AUN1.SGM 16AUN1 640

Agencies

[Federal Register Volume 70, Number 157 (Tuesday, August 16, 2005)]
[Notices]
[Pages 48160-48162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16281]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0218]


Vision 2006--A Conversation With the American Public; Notice of 
Public Meetings on Specific Food and Drug Administration Issues; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meetings; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of public meetings entitled ``Vision 2006--A Conversation With the 
American Public,'' in three cities. This forum will be an open format 
in which consumers can interact directly with the agency's leadership 
to discuss what is on the public's mind. It will also be an opportunity 
for the agency to update the public on current agency programs, engage 
the public in discussion, and obtain consumer input on specific

[[Page 48161]]

issues. We may use the public input we receive to evaluate and to 
propose modifications, if necessary, to our programs and activities.

DATES: See table 1, section III, of the SUPPLEMENTARY INFORMATION 
section of this document for meeting dates and times. See section IV of 
this document for information on how to register, to speak at, or to 
attend a meeting. Written or electronic comments must be received by 
November 30, 2005.

ADDRESSES: See table 1, section III, of the SUPPLEMENTARY INFORMATION 
section of this document for meeting locations. Submit electronic 
comments to https://www.fda.gov/dockets/ecomments. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For information about this document: Philip L. Chao, Food and Drug 
Administration (HF-23), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-0587, FAX: 301-827-4774, e-mail: philip.chao@fda.hhs.gov.
    For information regarding registration: Isabelle Howes, Graduate 
School, U.S. Department of Agriculture, 490 L'Enfant Plaza, Promenade 
Level, suite 710, Washington, DC 20024, 202-314-4713, FAX: 202-479-
6801, e-mail: Isabelle--Howes@grad.usda.gov.

SUPPLEMENTARY INFORMATION:

I. Why Do We Want to Hold Public Meetings?

    New medical products have played a critical role in improving the 
lives of millions of Americans, providing much-needed treatments and 
cures for a wide range of illnesses. New advances in food technology 
and nutrition have enabled consumers to improve their health and well-
being in countless ways. As we move forward in the 21st century, 
Americans are rightly concerned that advances in science should 
continue to translate into better products and technologies that can 
benefit their health.
    FDA lies at a critical juncture to enable these kinds of advances 
in science, technology, and health. The agency is responsible for 
protecting and promoting the public health by ensuring the safety and 
effectiveness of most human and animal drugs; biological products such 
as vaccines, cellular therapies, and blood; medical devices; tissues, 
and radiation-emitting products such as x-ray machines. We are also 
responsible for ensuring the safety and wholesomeness of food 
(including animal feed and dietary supplements) and cosmetics. Many 
Americans are rightly interested in FDA's programs, and the steps that 
the agency is taking to ensure that the promise of better science 
translates into longer lives with fewer problems from today's diseases. 
Consumers also want the opportunity to participate, in a meaningful 
way, in our work, whether we are discussing a complex scientific issue, 
proposing a regulation to address a particular problem, or implementing 
a new law.
    We are holding these public meetings to help enhance this dialogue. 
This series of meetings will be an open forum in which consumers can 
interact directly with the agency's top leadership, including its 
leading scientists, to discuss what is on the public's mind.
    We already provide similar opportunities for the public to engage 
in the agency's decisionmaking processes. We encourage people to take 
advantage of these regular opportunities to provide the agency with 
critical input into its programs. For example, the agency hosts 
frequent public meetings to discuss specific topics, reserves time 
during advisory committee meetings for public input, and invites the 
public to submit written or electronic comments on our rules. In 2004, 
we received more than 140,000 comments (including form letters) on 
rules, notices, and other matters. But the series of public meetings 
being announced in this document is a unique gathering of all of the 
agency's top leadership, including FDA Commissioner of Food and Drugs 
Lester Crawford, to provide direct feedback in an open forum on a broad 
range of issues of interest to the public.
    Through the public meetings we are announcing in this document, we 
are also offering an opportunity for the public to hear more about, and 
to give us input on, specific programs or initiatives that we are 
currently pursuing to better protect and advance the public health. 
Public input will help us shape the agency's agenda for 2006 and 
beyond, as we commence our second century of serving the American 
public. Among some of the topics that we hope to discuss at the 
meetings are new opportunities to advance the safe use of medical 
products, increase the public health benefits of direct-to-consumer 
advertising, guarantee the safety and reliability of dietary 
supplements, and improve the science of drug development by lowering 
the cost of new medical products and speeding access to better medical 
technologies through the agency's ``Critical Path'' initiative. We also 
hope to discuss our continuing efforts to increase public understanding 
of, and involvement in, the agency's scientific and regulatory 
processes--for example, through our advisory committee process and 
through improved, direct communication with consumers.
    Through this open dialogue, the agency's leadership hopes to gain 
valuable insight from those who benefit from its regulatory efforts. 
FDA appreciates all of the consumer interest in its activities, and the 
agency's programs have benefited greatly from the feedback FDA receives 
from its many constituencies. To increase the transparency of our 
decisionmaking process, we are developing new, and expanding existing, 
communications channels to provide targeted information about new 
products to the public. We believe patients, healthcare professionals, 
and consumers will find the information useful in their individual 
treatment decisions. In an era when more and more of the products that 
people use are personalized to their individual needs, especially 
medical products and dietary choices, communicating the unique risks 
and benefits of individual products, and matching them to patients' 
individual needs, becomes paramount.
    We want to ensure the information we provide and new efforts we are 
undertaking provide maximum value to consumers. Among the many 
questions we would like the public to consider are the following:
     What information do you expect to receive from FDA 
regarding the benefits and risks of new food and medical products?
     Where do you currently get information about these 
products, and how beneficial is this information in helping to inform 
the decisions you make?
     What additional information, if any, do you believe should 
be provided to enable you to discuss with your physician or other 
health care provider the benefits and risks of products for a health 
condition you have or think you might have?
     What additional steps can FDA take to improve its 
communication with consumers and build on your confidence in its 
activities and its mission?

II. How Should You Send Comments on the Issues?

    If you would like to submit comments on any of the issues discussed 
in this document, please send your comments

[[Page 48162]]

to the Division of Dockets Management (see ADDRESSES). Submit a single 
copy of electronic comments or two paper copies of any written 
comments, except that individuals may submit one paper copy. Comments 
should 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. 
To ensure consideration of your comments, we must receive any written 
or electronic comments by November 30, 2005.

III. Where and When Will the Meetings Occur?

    We will hold public meetings in three cities to discuss the issues 
described earlier in this document. The meetings are scheduled from 10 
a.m. to 4 p.m.
    The meeting dates, times, and locations are as follows:

                                  Table 1.--Meeting Dates, Times, and Locations
----------------------------------------------------------------------------------------------------------------
     Location                           Meeting Site Address                          Meeting Date and Time
----------------------------------------------------------------------------------------------------------------
Boston, MA          Boston Marriott Cambridge, 2 Cambridge Center (Broadway and  November 2, 2005, 10 a.m. to 4
                     3d St.), Cambridge, MA 02142                                 p.m.
----------------------------------------------------------------------------------------------------------------
Miami, FL           Intercontinental West Miami, 2505 Northwest 87th Ave.,       September 13, 2005, 10 a.m. to
                     Miami, FL 33172                                              4 p.m.
----------------------------------------------------------------------------------------------------------------
Phoenix, AZ         Phoenix Airport Marriott, 1101 North 44th St., Phoenix, AZ   November 30, 2005, 10 a.m. to 4
                     85008                                                        p.m.
----------------------------------------------------------------------------------------------------------------

IV. Do You Have to Register to Make a Presentation at or to Attend a 
Meeting?

    If you wish to make a presentation at or to attend any meeting, 
please register online at https://www.grad.usda.gov/vision at least 5 
business days before the appropriate meeting date. The online 
registration form will instruct you as to the information you should 
provide (such as name, address, telephone number, electronic mail 
address, topic(s) of interest, whether you wish to make a presentation, 
and which meeting you wish to attend). We also will accept walk-in 
registrations on the meeting dates. However, space is limited, and we 
will close registration at each site when maximum seating capacity for 
that site is reached (approximately 150 people per location).
    We will try to accommodate all persons who wish to make a 
presentation. The time allotted for presentations will depend on the 
number of people who wish to speak on a given topic, and the meeting 
schedule at each location. Similarly, the time allotted to each topic 
may vary depending on the expressed interests of persons registering 
for a particular meeting. To obtain updates on the meetings, please 
visit https://www.fda.gov/oc/initiatives/vision2006.html. Additionally, 
regardless of whether you wish to make a presentation or simply attend 
a meeting, if you need any special accommodations (such as wheelchair 
access or a sign language interpreter), please notify Isabelle Howes 
(see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the 
meeting.

V. Will Meeting Transcripts Be Available?

    We will prepare transcripts of each meeting. You may request a copy 
of a meeting transcript by writing to our Freedom of Information Office 
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857. We anticipate that transcripts will be available 
approximately 30 business days after the public meetings at a cost of 
10 cents per page. The transcripts will also be available for public 
examination at the Division of Dockets Management (HFA-305), 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: August 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16281 Filed 8-15-05; 8:45 am]
BILLING CODE 4160-01-S

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