Officials In Sanctuary Cities Condemn Trump’s Proposal To Move Immigrant Detainees

Officials In Sanctuary Cities Condemn Trump’s Proposal To Move Immigrant Detainees

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The president says he is considering sending detained immigrants in the country illegally to sanctuary cities. San Francisco is among the cities that have passed sanctuary city ordinances.

AUDIE CORNISH, HOST:

Officials in sanctuary cities are largely condemning President Trump’s proposal to move immigrant detainees from the border to those cities. There are almost 200 sanctuary municipalities, states and counties across the U.S. San Francisco is one of them. City leaders there say that although they would welcome migrants, they don’t think transporting them to the city is the best option. Sonja Hutson from member station KQED reports.

SONJA HUTSON, BYLINE: San Francisco’s had a sanctuary policy since 1989. It limits the ability of law enforcement to cooperate with federal immigration authorities. San Francisco Supervisor Sandra Lee Fewer says it’s an ordinance the city is proud of.

SANDRA LEE FEWER: In San Francisco, we don’t know who’s documented and who isn’t. Actually, we just live amongst each other, and we live peacefully.

HUTSON: While Fewer and other officials are denouncing the proposal, they’re also saying they would welcome the migrants if it goes through.

FEWER: We will treat them as human beings. We respect them as people. And we want their families to have a livelihood here, too.

HUTSON: Critics of sanctuary policies say they endanger residents. They point to the fatal 2015 shooting of a woman in San Francisco by an undocumented immigrant. That instance garnered national attention as an example of violence enabled by sanctuary policies. The immigrant, however, was acquitted of murder and manslaughter.

But supporters of the policy, like San Francisco Supervisor Rafael Mandelman, say they keep the city safe and help improve the well-being of immigrants.

RAFAEL MANDELMAN: It’s about immigrant communities being able to go to the police, be able to go to our public health resources. Our city will not be stronger if our immigrant communities feel that they can’t go to the police or can’t go see a doctor.

HUTSON: In addition to several major cities, including San Francisco, Oakland and Los Angeles, the entire state of California has a sanctuary policy. Kevin de Leon authored the sanctuary state law when he represented parts of Los Angeles in the state Senate. He says another concern is the cost of transporting these migrants.

KEVIN DE LEON: Wasting taxpayer dollars to put folks on a plane specifically to sanctuary cities is a non-starter.

HUTSON: San Francisco is more than 500 miles from the California-Mexico border. De Leon says the proposal has little to do with what’s best for immigration and more to do with agitating President Trump’s base in the run-up to the 2020 election.

DE LEON: It’s clearly not done to benefit the immigrants themselves, but rather to do everything within his power to embarrass elected official leaders throughout the state who have defended immigrants.

HUTSON: This isn’t the first time the Trump administration has singled out sanctuary cities. In 2017, it threatened to withhold law enforcement grants from nearly 30 jurisdictions. In the end, many courts determined the federal government could not withhold those grants.

But not everyone in California or San Francisco agrees with the elected leaders who put forth these policies. Harmeet Dhillon is the Republican National Committeewoman for California and a lawyer in San Francisco. She supports President Trump’s proposal to move immigrants to sanctuary cities. And she says the Democratic response to that suggestion has been hypocritical.

HARMEET DHILLON: Talk about political ploys and political pawns. Democrats have been using illegal aliens as political pawns and selling points and talking points for their pandering to the Hispanic vote for decades.

HUTSON: And Dhillon says city officials shouldn’t be welcoming large amounts of undocumented immigrants into places like San Francisco.

DHILLON: Actually, when you can’t take care of the health and welfare needs and educational needs of your own citizens, then you are a bad leader trying to dilute those resources amongst people who have not necessarily paid their dues to be here in this country.

HUTSON: Dhillon says sanctuary cities should focus on helping current residents, including large homeless populations in San Francisco, Oakland and Los Angeles. For NPR News, I’m Sonja Hutson in San Francisco.

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Inactive Ingredients Database Download

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Page Last Updated: 04/12/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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https://www.fda.gov/Drugs/InformationOnDrugs/ucm113978.htm

May 7, 2019: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

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Center Date Time Location
CDER May 7, 2019 9:00 a.m. to 4:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Agenda

The committee will discuss the following topics: (1) approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of ‘exposure-matching’ under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of ‘exposure matching,’ including the necessary assumptions and any limitations.

Meeting Materials

FDA intends to make background material available to the public no later than two (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 available at: 2019 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Public Participation Information

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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-1043. The docket will close on May 6, 2019. Submit either electronic or written comments on this public meeting by May 6, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 19, 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 April 29, 2019 will be provided to the committee. Comments received after that date but by May 6, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.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, such as a manufacturing process. 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 http://www.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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2019-N-1043 for “Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information 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 the 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. 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 April 22, 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 April 23, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 7, 2019 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. While CDER 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. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

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

Contact Information

  • 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 FDA’s website 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.

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

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

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 Jay Fajiculay (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation 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).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm635685.htm

Pulmonary-Allergy Drugs Advisory Committee Roster

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David J. Lederer, MD, MS
Expertise: Pulmonary and Interstitial Lung Disease
Epidemiology
Term: 12/21/2017 – 5/31/2021
Associate Professor of Medicine and Epidemiology
Division of Pulmonary, Allergy and Critical Care Medicine
Columbia University Medical Center
161 Fort Washington Ave, Rm 3-321A
New York, New York 10032

Gailen D. Marshall Jr., MD, PhD, FACP
Expertise: Allergy and Immunology
Term: 6/1/2018 – 5/31/2022
The R. Faser Triplett Sr MD Chair of Allergy and Immunology
Medical Director, UMMC Clinical Research Support Program/Clinical Research and Trials Units
Professor of Medicine, Pediatrics and Pathology
Vice Chair for Research, Department of Medicine
Director, Division of Clinical Immunology and Allergy
Chief, Laboratory of Behavioral Immunology Research
The University of Mississippi Medical Center
2500 North State Street N416
Jackson, Mississippi 39216

https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm107568.htm

Boeing To Slow Production Of 737 Max Jets As It Works On Flight Control Software Fix

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A Boeing 737 MAX 8 airplane sits on the assembly line on March 27, in Renton, Wash. Boeing is slowing production of its grounded Max airliner while it works on fixing flight-control software in the wake of fatal crashes. Ted S. Warren/AP hide caption

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Ted S. Warren/AP

A Boeing 737 MAX 8 airplane sits on the assembly line on March 27, in Renton, Wash. Boeing is slowing production of its grounded Max airliner while it works on fixing flight-control software in the wake of fatal crashes.

Ted S. Warren/AP

Boeing says it is reducing production of its 737 Max planes, and the temporary slowdown will begin in mid-April.

CEO Dennis Muilenburg says the company will build 42 of the planes per month, down from the current 52, while keeping the same number of workers. Boeing still has an enormous backlog of orders — about 4,600 — for the Max planes. That will take years to fill.

Muilenburg says he now knows that two deadly crashes within five months of each other, involving Lion Air and Ethiopian Airlines, had a common link of a malfunctioning flight-control software called MCAS.

He says he has asked Boeing’s board of directors to create a committee to review company policies for airplane development and recommend improvements.

Ethiopian Airlines released a preliminary report Thursday on the crash of its plane on March 10. Investigators say the pilots used procedures provided by Boeing but couldn’t stop the plane’s repeated nose dives. All 157 people on board died in the crash just after takeoff from Addis Ababa.

A Lion Air 737 Max jet crashed in a similar way on Oct. 9, with pilots frantically trying to stop the nose from dropping. The plane went down off the coast of Java, killing 189 people.

The 737 Max planes have been grounded worldwide for nearly a month as Boeing works on a software fix.

Provided By NPR

E-cigarette: Safety Communication – Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

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[Posted 04/03/2019] 

AUDIENCE: Consumers, Emergency Medicine, Health Professionals 

ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional or accidental swallowing of e-liquid. However, a recent uptick in voluntary reports of adverse experiences with tobacco products that mentioned seizures occurring with e-cigarette use (e.g., vaping) signal a potential emerging safety issue.  

RECOMMENDATIONS:

Healthcare Professionals should:

  • Ask patients about e-cigarette use (e.g., vaping), particularly when providing care following a seizure.

  • Consider testing cotinine levels, a nicotine metabolite, in addition to the typical urine toxicology screening tests.

  • Even in e-cigarette users, proceed with the usual work-up to identify or rule out other causes of seizures.

  • Refer all users for tobacco cessation assistance.

Redacted reports of past incidents are available on the FDA website and may assist medical evaluations of seizures.

Healthcare professionals and consumers are encouraged to report adverse events, or any problems related to these products to the Safety Reporting Portal.

 [04/03/2019 – Press Announcement – FDA] 

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm635240.htm

Boeing 737 Max Software Fix And Report On Fatal Crash Expected This Week

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This Ethiopian Airlines Boeing 737 Max 8, seen last Saturday, is one of those grounded following the crash that killed 157 people. Mulugeta Ayene/AP hide caption

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Mulugeta Ayene/AP

This Ethiopian Airlines Boeing 737 Max 8, seen last Saturday, is one of those grounded following the crash that killed 157 people.

Mulugeta Ayene/AP

Boeing says it has a software fix ready for its 737 MAX airplanes that will be unveiled to airline officials, pilots and aviation authorities from around the world Wednesday, as the aircraft manufacturer works to rebuild trust among its customers and the flying public following two fatal crashes of the planes in recent months.

Meanwhile, those crashes and the relationship between Boeing and the federal agency charged with regulating it will be discussed at a U.S. Senate aviation subcommittee hearing on Wednesday. Scheduled to testify are the heads of the Federal Aviation Administration and the National Transportation Safety Board, along with the Transportation Department’s inspector general, who is investigating the how the FAA went about certifying the 737 MAX as airworthy, and whether regulators relied too heavily on Boeing’s own safety assessments in their review.

Those developments come as transportation authorities in Ethiopia prepare to release preliminary findings on the cause of the crash of an Ethiopian Airlines Boeing 737 MAX 8 plane earlier this month that killed all 157 people on board.

A spokesman for Ethiopia’s transport ministry told the Associated Press “a date has not been set but (the preliminary report) will be released later this week.” The spokesman says the U.S. National Transportation Safety Board, France’s aviation investigative authority BEA, and Ethiopia’s Transport Ministry have been conducting the investigation jointly.

The investigators have said there were striking similarities between the March 10 crash outside of Ethiopia’s capital city Addis Ababa and the crash of a Lion Air Boeing 737 MAX 8 into the Java Sea in Indonesia last October. Both planes crashed shortly after takeoff and both followed similar, erratic flight tracks in the air that indicate the pilots may have been struggling to try keep the planes from going into nosedives.

In the Lion Air jet crash October 29, which killed all 189 people on board, Indonesian investigators say an automated flight control system, acting on erroneous data from a faulty sensor, repeatedly forced the nose of the plane down. That system, called MCAS, for Maneuvering Characteristics Augmentation System, is designed to prevent the airplane from stalling. But the Lion Air pilots apparently did not know how to counteract the system or disengage it, and were in a futile struggle to regain control of the plane.

After the Lion Air crash, many pilots complained that had not been made aware of the MCAS system, as it did not exist on previous versions of the 737, nor had they been trained on what to do when the system engages and forces the nose of the plane downward unexpectedly.

It still is not clear if something similar happened on the Ethiopian Airlines jet but the company’s CEO says pilots had been trained on how to handle the new system after the Lion Air crash.

Boeing officials say the company has completed developing software upgrades for MCAS aimed at preventing such occurrences in the future. The system will no longer act repeatedly in forcing the nose of the plane and will act just once if detecting the plane entering an aerodynamic stall. And the MCAS system will rely on data from the two angle of attack sensors on the plane, instead of just one.

In addition, a warning light that alerts the pilot when the angle of attack sensors disagree will become standard instead of being a more expensive option for airlines to purchase, and it will be added to the entire fleet of 737 MAX aircraft for free.

A Boeing official says the software upgrades have undergone extensive lab and simulator testing, with pilots in a simulator facing a series of errors and failures, including sensor errors and other erroneous inputs.

The Boeing official says the FAA participated in the evaluation, even demonstrating the software upgrades during a test flight on March 12.

It is unlikely that the FAA will act quickly in certifying the software upgrades and other fixes, especially considering the scrutiny of the certification process coming from Congress and others. And regulators in Canada, Europe, China and other countries say they will no longer rely on FAA data and will conduct their own tests of the MCAS software updates before allowing Boeing’s 737 MAX planes in the air again. As a result, some experts say it could be months before the airplanes are allowed back into service.

Provided By NPR

April 26, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER April 26, 2019  8:30 a.m. to 1:00 p.m.
 
Tommy Douglas Conference Center
10000 New Hampshire Ave.
Silver Spring, MD 20903

Agenda

The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

Meeting Materials

FDA intends to make background material available to the public no later than two (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 available at: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee).

Public Participation Information

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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0795. The docket will close on April 25, 2019. Submit either electronic or written comments on this public meeting by April 25, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 25, 2019. 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 April 11, 2019, will be provided to the committee. Comments received after that date but by April 25, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.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, such as a manufacturing process. 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 https://www.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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2019-N-0795 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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.” The Agency 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. 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 April 3, 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 April 4, 2019.

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the April 26, 2019 Antimicrobial Drugs Advisory Committee meeting.

Contact Information

  • 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 FDA’s website 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.

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

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

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 Kalyani Bhatt (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation 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).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634408.htm

April 25, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER April 25, 2019  8:30 a.m. to 4:30 p.m.
 
Tommy Douglas Conference Center
10000 New Hampshire Ave.
Silver Spring, MD 20903

Agenda

The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis.

Meeting Materials

FDA intends to make background material available to the public no later than two (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 available at: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee).

Public Participation Information

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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0747. The docket will close on April 24, 2019. Submit either electronic or written comments on this public meeting by April 24, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 24, 2019. 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 April 11, 2019, will be provided to the committee. Comments received after that date but by April 24, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.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, such as a manufacturing process. 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 https://www.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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2019-N-0747 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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.” The Agency 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. 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 April 3, 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 April 4, 2019.

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the April 25, 2019 Antimicrobial Drugs Advisory Committee meeting.

Contact Information

  • 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 FDA’s website 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.

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

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

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 Kalyani Bhatt (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation 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).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634398.htm

May 8, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER May 8, 2019 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland 20993

Agenda

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

Meeting Materials

FDA intends to make background material available to the public no later than two (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 available at: 2019 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee.

Public Participation Information

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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0983. The docket will close on May 7, 2019. Submit either electronic or written comments on this public meeting by May 7, 2019. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 7, 2019. 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 April 24, 2019 will be provided to the committee. Comments received after that date but by May 7, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.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, such as a manufacturing process. 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 https://www.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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2019-N-0218 for “Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information 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 the 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 April 16, 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 April 17, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 8, 2019 meeting of the Pulmonary-Allergy Drugs Advisory Committee. While CDER 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. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: https://www.fda.gov/AdvisoryCommittees/default.htm.

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

Contact Information

  • 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 FDA’s website 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.

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

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

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 Cindy Chee (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation 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).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634382.htm

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