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Agenda

The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.  The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. 

The Agency seeks input and recommendations on: 

1. how information in PLLR labeling is being perceived and used by health care providers and other stakeholders,
2. factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and
3. how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

Meeting Materials

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 on the RCAC meeting materials page.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA established a docket for public comment on this meeting.  The docket number is FDA-2017-N-6925.  The docket will close on April 6, 2018.  Submit either electronic or written comments on this public meeting by April 6, 2018.  Please note that late, untimely filed comments will not be considered.  Electronic comments must be submitted on or before April 6, 2018.  The Regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 6, 2018.  Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before February 26, 2018 will be provided to the committee.  Comments received after that date will be taken into consideration by FDA.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: Regulations.gov.  Follow the instructions for submitting comments.  Comments submitted electronically, including attachments, to Regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on Regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:  All submissions received must include the Docket No. FDA-2017-N-6925 for "Risk Communication Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments."  Received comments, those filed in a timely manner (see ADDRESSES) will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at Regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.  You should submit two copies total.  One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION."  FDA will review this copy, including the claimed confidential information, in its consideration of comments.  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on Regulations.gov.  Submit both copies to the Dockets Management Staff.  If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.  For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: Consumer Comments-Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets.

Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to docket FDA-2017-N-6925 on Regulations.gov and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.

Written submissions may be made to the contact person on or before February 26, 2018.

Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 p.m. on March 5, 2018, and between 9:10 a.m. and 9:30 a.m. on March 6, 2018.  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 February 16, 2018. 

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 February 20, 2018.

Webcast Information

FDA plans to provide a free-of-charge, live webcast of the March 5 and 6, 2018, meeting of the Risk Communication Advisory Committee. While FDA works to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.

Interested persons can visit https://collaboration.fda.gov/rcac/ to hear and see the proceedings.

FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
 

Contact Information

Lee L. Zwanziger, Ph.D., Designated Federal Official
10903 New Hampshire Ave., Building 32, Room 3363
Silver Spring, Maryland 20993

Phone: (301) 796-9151
Fax: (301) 847-8611
E-mail: [email protected]

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.

For press inquiries, please contact the Office of Media Affairs at [email protected] or (301) 796-4540.

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 Lee L. Zwanziger at (301) 796-9151 least seven (7) days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at Public Meetings on the FDA White Oak Campus. Please note that visitors to the White Oak Campus must enter through Building 1.

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 Advisory Committees web page 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.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our web site at Public Conduct During FDA Advisory Committee Meetings 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). Official FR Notice

 

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