FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION
Transmittal Number 81-34 -- Date: 03/06/1981
|3. Reporting Guidelines|
Attachment A - Public Calendar Format - Forms FDA 3174, 3174a, 3174b, and 3174c
This guide provides for the preparation and distribution of a weekly FDA Public Calendar, which will provide a record of meetings held during the previous week, both open and closed, between FDA officials and personnel outside the Executive Branch of the Federal Government. It also provides for the preparation of reports by designated FDA officials of their participation in these activities. In addition, the FDA Public Calendar will announce public proceedings involving FDA which are scheduled to be held during the following four weeks. (Format for the Calendar is shown as Attachment A.)
A. Office of Public Affairs (OPA). OPA is responsible for receiving the reports of meetings and events from designated officials, and for compiling and editing the information for publication as the Public Calendar. OPA is also responsible for distribution of the Calendar, according to the following list:
1. Dockets Management Branch
2. OPA (Parklawn and FOB 8)
3. A central place in each bureau
4. A central place in each field office
5. A central place at NCTR
The calendar will be issued each week by close of business Friday. Reports from officials must be received by 10:30 Friday morning in the Office of Public Affairs, HFI-1, Room 15B-42, Parklawn Building.
B. Designated Officials. The officials listed below are required to report meetings and events if they are the presiding or head FDA representative at the meeting. All other FDA participants of the same meeting need not submit a report. The official responsible for submitting the report also is responsible for responding to public requests for summary minutes of the meeting, if such minutes are available, or any other materials available, such as the text of speeches (OPA will be responsible for providing copies of speeches by the Commissioner and Deputy Commissioner). The following officials and their deputies, or any official acting in that capacity, are responsible for reporting attendance at meetings and similar events:
1. Commissioner of Food and Drugs
2. Deputy Commissioner
3. Special Assistants to the Commissioner
4. Associate Commissioners
5. Bureau Directors
6. Executive Director for Regional Operations
7. Director, National Center for Toxicological Research
8. Chief Counsel, FDA
C. All FDA Officials. All FDA officials including those listed above are responsible for reporting upcoming public meetings, seminars, conferences, and other public proceedings which have not been published in the FEDERAL REGISTER, for inclusion in the prospective Calendar.
D. Office of Legislative Affairs. OLA is responsible for reporting to OPA all Congressional hearings involving FDA for inclusion in the retrospective Calendar.
3. REPORTING GUIDELINES
All reports should be simple and easy to understand. The following lists the information which is necessary for compiling the Public Calendar and provides guidelines for uniformity in reporting style:
1. Retrospective Calendar. Lists meetings, conferences, seminars, social events sponsored by regulated industry, speeches, and other significant events held or attended by designated FDA officials the previous week (Friday through Thursday) with persons outside the Executive Branch of the Federal Government. The following information should be included:
a. FDA Official and Title. Name and title of reporting official. Do not abbreviate. It is not necessary to repeat the name and title for each meeting.
b. Date and Location. Specify the location of meetings at FDA, such as "FDA-Rockville" or "FDA-Washington." For other locations, list city and state.
c. Other FDA Participants. List names only. Omit prefixes such as "Mr." or "Mrs." and use "Dr." in lieu of M.D., PhD., etc. If more than five FDA personnel attend the meeting, list "several officials," or "several Bureau of Foods staff members," or "several FDA officials and staff members," etc.
d. Non-FDA Participants. Omit prefixes, use Dr. in lieu of M.D., etc. Include the title (if President, Chairman of the Board, or other high official) and affiliation of each person reported. If more than one person from a particular company attends a meeting, list all names and titles first, then the company they are with. If more than five persons from one company attend, list "several representatives" from the company. If a participant is not an employee of a particular firm but is representing one, i.e., lawyers -- be sure to list the firm they are representing.
e. Subject. Be brief. List only the main topic of the meeting, and do not include the word "discussed." Precede the subject with an asterisk (*) if minutes will be available. Contacts or interviews with members of the working press (except publications of firms that manufacture or distribute regulated products, or industry associations); contacts with on-site contractors; and telephone conversations or meeting which might compromise regulatory enforcement activities or constitute an invasion of privacy (i.e., an employment interview) are not reported.
2. Prospective Calendar. Lists all open, public meetings, conferences, hearings, advisory committee meetings, seminars, and other public proceedings to be attended by any FDA officials for the following four weeks. DOES NOT include meetings which are or will be published in the FEDERAL REGISTER. The following information should be included:
a. FDA Official Reporting. List full name and title, no abbreviations.
b. Meeting or Event and Subject.
c. Date, Time, and Place. List month, day, and time; list room number, building, and address of location.