1. Cid 7 March 2019 Dates
2. Cid 7 March 2019 Schedule

On This Page

The agreement with Thames Water had progressed with completion programmed for late March 2019. Under this agreement, the Council would reconcile Thames Water’s incurred costs to date as well as fund legal, professional fees and design costs leading to the submission of the planning application for the sewage treatment works. March 7-9, 2019 ASAC Clemson, NC Read More; March 8-9, 2019 AHHS LIMITED BREEDER’S STALLION SERVICE AUCTION Fishers, IN Read More; March 8-9, 2019 UPHA CHAPTER 16 SPRING HORSE SHOW Tampa, FL Read More; March 9, 2019 KANAWHA VALLEY HORSEMEN’S ASSOCIATION WINTER TOURNAMENT.

Location:

White Oak Campus: The Great Room
The Great Room

10903 New Hampshire Ave
Bldg 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD20993
United States

Center	Date	Time	Location
CBER	March 6, 2019	8:00 a.m. to 4:30 p.m.	FDA White Oak Campus, White Oak Conference Center, Building 31, Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993
CBER	March 7, 2019	8:30 a.m. to 4:45 p.m.	FDA White Oak Campus, White Oak Conference Center, Building 31, Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993

Agenda
On March 6, 2019, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season. Also under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses (LR), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.

On March 7, 2019, under Topic III, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur.

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 website 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 website after the meeting.

Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.

Public Participation Information
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 February 27, 2019.

• On March 6, 2019, oral presentations from the public will be scheduled between approximately 11:10 a.m. and 11:55 a.m. for the influenza strain selection portion of the meeting and 3 p.m. to 3:15 p.m. for the overview portion of the LIR/LR Site Visit. On March 7, 2019, oral presentations from the public will be scheduled between approximately 1:15 p.m. to 2:15 p.m. for the Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur portion of the meeting.

Closed Committee Deliberations: On March 6, 2019, from 3:25 p.m. to 4:30 p.m., the meeting will be closed to Public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).

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 19, 2019. 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, 2019.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

For those unable to attend in person, the meeting will also be available via webcast.

Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. While CBER is working 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. The link for the webcast (both days) is available at:
https://collaboration.fda.gov/vrbpac032019/

Contact Information

• CAPT Serina Hunter-Thomas, 240-402-5771, e-mail: serina.hunter-thomas@fda.hhs.gov or Ms. Monique Hill, 301-796-4620, e-mail: monique.hill@fda.hhs.gov
• 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.

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 meetings main pageor call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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 Serina Hunter-Thomas at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public meetings at White Oak main page.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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).

Recorded Webcast

1. Day 1
2. Day 2

Event Materials

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.

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 and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

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).

• Regulated Product(s)

March can be a long month, and that’s especially true for cinephiles. Wedged between the Oscars and the start of the summer movie season (which now begins sometime in April), the tail-end of winter can feel like the deepest of doldrums on the annual movie calendar. Fortunately, Netflix is doing what it can to sustain its subscribers from now until spring.

This month’s new additions to the company’s streaming library offer a little something for everyone, from the soaring acrobatics of “Crouching Tiger, Hidden Dragon,” to the chilled mysteries of Debra Granik’s “Winter’s Bone,” and the heartbreaking drama of Asghar Farhadi’s “A Separation.” March’s Netflix Originals include Chiwetel Ejiofor’s directorial debut, Lukas Dhont’s controversial “Girl,” and the star-studded beefcake spectacle of “Triple Frontier.” “Music and Lyrics” and “Nick and Norah’s Infinite Playlist” join the internet’s deepest stable of 21st century rom-coms, while Stanley Kubrick’s “A Clockwork Orange” is added to the internet’s most pathetic roster of pre-’90s cinema. “The Lives of Others” and “The Hurt Locker” might help with your post-Oscar hangovers, while Stephen Chow’s “Kung Fu Hustle” is coming to remind you that the movie world is richer and more wonderful than awards season might suggest.

Here are the seven best movies new to Netflix in March 2019.

7. “The Boy Who Harnessed the Wind” (2019)

Chiwetel Ejiofor’s solid and engaging directorial debut tells the incredible true story of 13-year-old William Kamkwamba (Maxwell Simba), the self-educated son of two poor farmers who taught himself how to build a windmill in order to save his desperate Malawian village from an onslaught of disasters. Without the shading and self-doubt that Ben Nabors’ 2013 documentary “William and the Windmill” found in the real Kamkwamba, Ejiofor struggles to make his protagonist feel like more than a symbol — it can be difficult to dramatize the development of an exceptional young mind, especially when a filmmaker has too much integrity to go full “Good Will Hunting” — but the kid at the center of this drama is far from the only compelling thing about it.

Trywell Kamkwamba, William’s father, is one of the most nuanced characters that Ejiofor has ever played. An uneducated Malawian farmer who strives to provide schooling for his children, Trywell is too dignified to sell the family’s ancestral land to the tobacco business, and too savvy to think he can redeem his future by surrendering his past. He’s an honest man in a village that’s being choked to death by corruption, and — as a national food crisis takes hold — Trywell grows too desperate to see that his young son might be the only one who can save the farm and ensure its harvest. Caught in a vulnerable position between tradition and aspiration, he’s the heart and soul of this inspirational saga, and Ejiofor’s conflicted performance is powerful enough to energize the rest of his uplifting film.

Available to stream March 1.

6. “Nick and Norah’s Infinite Playlist” (2008)

In some respects, “Nick and Norah’s Infinite Playlist” hasn’t aged particularly well. A teen rom-com that’s set during (and thoroughly defined by) a New York indie rock scene that lasted for the length of an Interpol song, Peter Sollett’s follow-up to “Raising Victor Vargas” was never going to age particularly well. On the other hand, good movies have a way of surviving their own obsolescence, of proving themselves to be more of a time capsule than a relic, and this charming downtown adventure is growing up along those lines.

A far cry from the MP3-era “Thin Man” reboot its title might suggest, the film stars Michael Cera as a Michael Cera type, and Kat Dennings as the sullen Manhattanite he meets at Arlene’s Grocery, the two of them crushing hard on each other across a wild night that takes them to every Brooklyn Vegan-approved venue in the city. It’s a starry-eyed blast, full of raw emotion and topped off by an all-time Ari Graynor, great in the role of Norah’s very drunk friend, Caroline. She’s a key reason why “Nick and Norah’s Infinite Playlist” will likely be playing on cable (and maybe even streaming on Netflix) long after the last Bishop Allen fan has forgotten that band ever existed — it’ll never grow old, because it so vividly captures what it feels like to be young.

Available to stream March 1.

5. “Apollo 13” (1995)

Before “First Man,” before “Gravity,” and — as confusing as it might sound — before “Apollo 11,” there was “Apollo 13,” the movie that launched Hollywood into the space age. No, Ron Howard’s Best Picture-nominated blockbuster was not the first major film to take place in the cosmos (everyone from George Méliès to George Lucas had already gone to the stars and back), but “Apollo 13” achieved a verisimilitude that had never been seen before, using unsimulated weightlessness and cutting-edge special effects to make viewers feel as though Tom Hanks, Kevin Bacon, and Bill Paxton were actually drifting from the Earth to the Moon. Like “Titanic,” “Jurassic Park,” and the rest of the 90s’ most durable cinematic spectacles, “Apollo 13” hasn’t aged a day. In some ways, this story of American disaster and resilience might be even more resonant than the recent big-screen forays into space. It takes a lot courage to shoot for the stars, but it might take even more to survive what happens when you fall short.

Available to stream March 1.

4. “Winter’s Bone” (2010)

Last year was hardly the first time that “Leave no Trace” writer-director Debra Granik was overlooked for her work on a major new film. Despite “Winter’s Bone” earning four nods at the 2011 Academy Awards — including one for Best Actress contender Jennifer Lawrence, whom this film launched into the stratosphere — Granik didn’t make the cut for Best Director, a trophy that ultimately went to Tom Hooper for “The King’s Speech.” Yikes.

But the lack of little gold men speaks to a film that was always going to be a little too feral and unvarnished for tuxedos and champagne and the other trappings of mainstream success. The story of a 17-year-old girl in the mountains of Missouri whose coming of age takes a violent turn when her meth dealer father goes missing, the film offers a mercilessly honest portrait of a family splintered by economic hardship, and of a young woman who’s forced to dig up her roots in order to keep her siblings whole. Revisiting “Winter’s Bone” in the wake of Lawrence’s supernova stardom — or even watching it for the first time, knowing that it was even capable of minting a generational movie star — it can be surprising to see how rough and realistic this frigid Ozark mystery really is. It hasn’t lost a (tear)drop of its power.

Available to stream March 1.

3. “A Separation” (2011)

If you haven’t seen Asghar Farhadi’s unforgettable drama, now is the perfect time to catch up; later this year, when critics assemble their lists of the decade’s best films, “A Separation” is going to be on virtually every one of them. Winner of the Golden Bear, the Golden Globe, and the Academy Award for Best Foreign Language film, this even-handed stunner leverages a custody battle into an unsparingly human exploration of the ties that bind families together in Iranian society.

The story couldn’t be simpler: A woman named Simin (Leila Hatami) wants to leave the country with her husband, Nader (Peyman Moaadi) and their young daughter, Termeh (Sarina Farhadi), as she doesn’t want to raise a girl in a society that would limit her freedoms. Nader, who’s responsible for the care of his senile father, has other priorities. And so Simin decides to file for divorce. Needless to say, the courts don’t see the merits of her case, and a loving couple with differing needs begins to splinter into one of the most fractious and morally fraught breakups the cinema has ever seen. Honest, unsparing, psychologically complex in the way that movies seldom are, “A Separation” proved that Farhadi is one of the world’s greatest screenwriters, and launched the “About Elly” auteur into the upper echelon of contemporary filmmakers.

Cid 7 March 2019 Dates

Available to stream March 15.

2. “A Clockwork Orange” (1971)

Cid 7 March 2019 Schedule

When the IndieWire staff ranked the films of Stanley Kubrick, “A Clockwork Orange” came in fifth, putting it above the likes of “Eyes Wide Shut,” “The Killing,” and “Paths of Glory.” If that isn’t enough to convince you of its greatness, allow Toolkit Editor Chris O’Falt to explain why this deranged masterpiece amounts to more than the sum of its most iconic sequences:

The social satire of “A Clockwork Orange” has become an accepted part of popular culture, which somewhat masks its status as one of Kubrick’s most heady and most risk-taking works. Adapted from Anthony Burgess’ 1962 book, it tells the story of Alex (Malcolm McDowell, in one of those roles that sticks to an actor for decades) and his crew of “droogs,” a group of violent juvenile delinquents in a future dystopia. In a film that explores the potential dangers of how behavioral psychology could be used by a totalitarian government, Kubrick was uncharacteristically open in announcing the film’s themes he was exploring. He wrote: “It is a story of the dubious redemption of a teenage delinquent by condition-reflex therapy. It is, at the same time, a running lecture on free-will.”

The film’s subversive brilliance is how Kubrick uses cinema to not only make Alex and his “droogs” palatable, but also uncomfortably entertaining. Kubrick constantly, but expertly, teeters on the line of identification and satire of his nihilistic characters who beat, rape, and steal. In a unique combination of music and costuming — because what thug doesn’t wear white leotards, a black derby, and love to kick back to some Beethoven — Kubrick created a cartoonish version of cool, and confronted the audience with its moral attitudes about the constraints of society, government, and the concept of free will.

Available to stream March 1.

1. “Crouching Tiger, Hidden Dragon” (2000)

Almost 20 years since “Crouching Tiger, Hidden Dragon” reignited the traditional Chinese genre of wuxia and invited the entire world to feast on its wonders, Ang Lee’s soaring, swooning masterpiece is every bit as glorious as it was on the day it came out. Chow Yun-fat, Michelle Yeoh, Zhang Ziyi, and Chang Chen all give career-best performances in this woozy (and still heartbreaking) epic about star-crossed lovers who trip over their own destinies, but the real star remains martial arts guru Yuen Woo-ping, whose balletic fight choreography is some of the best ever committed to screen. From the stunning rooftop showdown that kicks off the first action sequence, to the iconic treetop duel some two hours later, the combat here is almost supernaturally fluid. And that’s because the film’s violence is never for its own sake. On the contrary, every punch, kick, and swing of a sword is an urgent act of self-expression, as these unforgettable characters lash out at a world they long to transcend.

The climactic showdown between legendary warrior Shu Lien and the upstart Jen marks a pivotal shift in the movie, as it’s the first (and only) time that any of the main characters aren’t just sparring with each other. The tenuous maternal bond between these two Wudan masters — a hardened warrior and her gifted but impetuous disciple — is finally strained to the breaking point in the worst possible setting: A remote training facility that’s stocked with a full armory of very sharp weapons. The acrobatic melee that ensues is the closest thing we’ll ever get to a Shaw brothers remake of “Lady Bird,” as two aggravated women try to reconcile their vast individual strength into some kind of sustainable harmony…even if it kills them both in the process. No fight to the death has ever been so full of life.

Available to stream March 1.

Sign Up: Stay on top of the latest breaking film and TV news! Sign up for our Email Newsletters here.