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Winter Weather:  Learn What You Can Do To Stay Safe and Warm When Winter Weather Threatens - Department of Homeland Security

Be Informed:  Know what disasters could affect your area, how to get emergency alerts, and where you would go if you and your family need to evacuate. Check out the related links to learn what to do before, during and after each type of emergency.

Snowstorms and Extreme Cold


USITC Makes Determination in Five-Year (Sunset) Review Concerning Circular Welded Pipe and Tube from Brazil, India, Korea, Mexico, Taiwan, Thailand, and Turkey - United States International Trade Commission

BULLETIN

The U.S. International Trade Commission has made affirmative determinations in its five-year (sunset) reviews concerning Circular Welded Pipe and Tube from Brazil, India, Korea, Mexico, Taiwan, Thailand, and Turkey.

Note to Users:  This bulletin will be replaced by the news release when the release is available. News releases are generally issued approximately three hours after a Commission vote.


USITC:  New Releases, New Documents and Announcements

The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. The new steps we’re announcing today go toward achievement of this third goal. We expect to take additional steps this year to promote competition; to help reduce drug prices and improve access to medicine for Americans.

Specifically, the FDA is releasing two documents today that together will streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs). The first is a draft guidance for industry – "Good ANDA Submission Practices" – which highlights common, recurring deficiencies we see in generic drug applications that may lead to a delay in their approval. One key reason why generic approvals are delayed is that many applications need to undergo multiple cycles of review. While often this is because the application lacks sufficient scientific evidence to support approval, there are also many times when the FDA must ask applicants for additional information in order to determine that the requirements for approval have been met, even if an application meets the threshold requirements for filing. In fact, it currently takes on average about four cycles for an ANDA to reach approval – not necessarily because the product will not meet our standards, but sometimes because the application is missing information necessary to demonstrate that it does. These multiple cycles of review are costly and inefficient. They require a great deal of additional, avoidable work by both agency staff and the applicant and can delay the entry of generic competition. Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018 - to reduce the number of review cycles - by helping applicants avoid these common deficiencies that lead to review delays and application cycling.

While industry does its part to improve the quality and completeness of applications, the FDA also is taking new steps to enhance the efficiency of our review process. Today, we’re publishing a companion to the guidance in the form of a Manual of Policies and Procedures (MAPP) – "Good ANDA Assessment Practices" – which outlines ANDA assessment practices for FDA staff. The document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete.

Among other things, the new MAPP establishes that when the FDA determines that an ANDA cannot be approved in its current form, reviewers should provide more detail to generic applicants to explain the deficiencies with the application; outline details on how this information should be provided; and provide more detail, when available, on the additional information that the generic applicant must provide to the agency to support an approval decision during the next application cycle. The MAPP establishes these practices across offices charged with ANDA review, including the Office of Generic Drugs as well as the Office of Pharmaceutical Quality. The goal is to make sure that generic drug makers are made fully aware of the problems that are delaying the approval of their application and understand how to fix them. As with the draft guidance on submission practices, this MAPP should reduce the number of subsequent cycles that applications must undergo, and avoid the cycling of applications that is a significant cause of the delays in generic approvals. The MAPP also clarifies the roles and responsibilities of different review disciplines to reduce inconsistencies as well as duplicative and unnecessary work. This will greatly increase the efficiency and effectiveness of the agency’s generic drug review teams. As the new MAPP states, "Collectively, these changes are expected to expand access to generic medicines," and enable the FDA’s "highly trained experts to focus more of their attention on novel or challenging scientific and policy issues associated with the development and assessment of generic drug products."

This new MAPP does not alter the important Generic Drug User Fee Amendments II review goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval. Rather, the goal of the MAPP is to guide FDA staff to help ensure we work more efficiently with the goal of improving review times.

The FDA’s generic drug team already has made substantial investment in process improvements that are yielding faster assessment and approval times, translating to direct benefits for consumers through more approvals of lower-cost drug options. In 2017, we had several record-breaking months for the number of generic medicines approved in a single month, most recently in November, when we approved the highest number of generic medicines in the FDA’s history. For the full year, the FDA approved a record number of generic drugs, including first generics, high-priority medications, and drugs meeting vital public health needs. In addition to the increase in the volume of drugs being approved, the average number of review cycles needed to approve each eligible application is decreasing. The FDA took action on more applications in the last six months of 2017 than any other six-month period in FDA history.

The policies we’ve announced today and those that we’re anticipating in early 2018 represent our ongoing work on the Drug Competition Action Plan— one of the FDA’s highest priorities in 2018. In the coming year, we’ll be taking additional steps to improve our own practices and to help guide industry to make sure their generic drug applications can be acted upon as efficiently as possible. For example, we’ll be building on our initiatives to accelerate generic entry of complex generics, which include medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs, which are sometimes hard to copy.

We’ll also continue to take steps aimed at making it harder for brand companies to sometimes adopt tactics that prevent generics from coming to market in the time frame that the law intended. This includes guidance development to address three important areas during the first quarter of 2018: potential abuses of the citizen petition process, companies that restrict access to testing samples of branded drugs, and abuses of the single, shared system REMS negotiation process.

It’s part of our public health mission to ensure safe, effective, quality medicines are available to the patients that need them. Most importantly, the FDA will continue to be the gold standard for approval of all drug applications, and we will make sure that consumers can continue to trust in that assessment.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


CPSC Offering $1.1 Million in Pool Safely Grants to Help Prevent Drownings and Drain Entrapments; State and Local Governments Encouraged to Apply - Consumer Product Safety Commission

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) today  announces a 90-day solicitation seeking applications for a special Pool Safely Grant Program (PSGP) offered to state and local governments. CPSC expects to award $1.1 million in two-year grants to assist jurisdictions in reducing deaths and injuries from drowning and drain entrapment incidents in pools and spas. The Pool Safely grant program is a part of CPSC’s national effort to make drowning and drain entrapment prevention a critical public safety priority.

The grant program is made possible through the Virginia Graeme Baker Pool and Spa Safety Act (VGB Act), legislation that was authored and advanced by Rep. Debbie Wasserman Schultz (D) Florida. Congress passed the VGB Act, and President George W. Bush signed the measure into law, in December 2007. The PSGP seeks to provide state and local governments with assistance for education, training and enforcement of pool safety requirements.

“These grants provide critical support for state and local officials to educate consumers about   drowning and entrapment dangers and to enforce pool safety laws in their communities,” said CPSC Acting Chairman Ann Marie Buerkle. “During this 10-year anniversary of the VGB Act, we are recognizing the important role of the VGB grant program in helping to reduce the  number of drowning and drain entrapment incidents. These funds will assist state and local programs to continue this lifesaving work to reduce such tragedies.”

Applicants must be a state or local government or U.S. Territory that has an enacted or amended state and/or local law(s) that meet the requirements in Sections 1405 and 1406 of the Virginia Graeme Baker Pool and Spa Safety Act (15 U.S.C.  §§ 8004 and 8005). 

Prospective applicants are encouraged to review the solicitation on Grants.gov, under grant opportunity CPSC-18-001. Applications will be accepted through April 2, 2018.

CPSC’s website: www.PoolSafely.gov, has supplemental information about the Pool Safely Grant Program and the VGB Act.  PoolSafely.gov has a broad range of free, downloadable information for the general public, state and local officials, the swimming pool and spa community and the media. 

The requirements of this child safety law will help to reduce the risk of drowning. The requirements include installing new safety drain covers and physical barriers, such as a fence completely surrounding the pool with self-closing, self-latching gates, and, if the house forms a side of the barrier, using alarms on doors leading to the pool area and/or a power safety cover over the pool.  See additional pool safety tips at: www.PoolSafely.gov.


Recycling Christmas Trees for Wildlife - U.S. Fish & Wildlife

Giving new life to your tree after the holiday season

Each year, about 25–30 million real Christmas trees are sold in the United States, mostly from a selection of about 16 species of tree that we commonly call a “Christmas Tree.” Decorated with lights and ornaments, they become backdrops for family photos, and serve as a resting place under which we put gifts to loved ones.

Ultimately, the day comes when they have served their purpose for the holiday. Don’t just trash them! Often these trees can benefit your local wildlife, the soil in your yard, or even nearby restoration projects.

After you’ve removed all the plastic bags, tinsel, and ornaments, here are some easy ways for you to help wildlife or enrich your local area with these trees after you’ve enjoyed them.

Ultimately, the day comes when they have served their purpose for the holiday. Don’t just trash them! Often these trees can benefit your local wildlife, the soil in your yard, or even nearby restoration projects.

After you’ve removed all the plastic bags, tinsel, and ornaments, here are some easy ways for you to help wildlife or enrich your local area with these trees after you’ve enjoyed them.

Create a Brush Pile with Your Tree

The easiest thing you can do if you have a yard? Create a brush pile! A brush pile often consists of leaves, logs, and twigs so an old Christmas tree can make a great base. It directly benefits the wildlife in your backyard during winter months because brush piles and dead trees offer food and needed protection from the weather. While we understand that not all communities allow for them, check locally to see if it’s a possibility.

Help Enrich Fish Habitat and Prevent Erosion

There are all sorts of great local projects that take in Christmas trees and use them for restoration projects. And it’s possible your community is already working to donate trees to these efforts. Several curbside tree recycling programs help create bird and fish habitat. Bayou Savage National Wildlife Refuge uses a number of New Orleans’ recycled Christmas trees that are collected to establish a wave break in open ponds on the refuge. Other projects have helped provide fish habitat, restore dunes and prevent erosion, provide electricity, and mulch. You can also donate it to local wildlife rehab centers, give it to goats When in doubt, check-in with your local wildlife rehab center to see if they could use it or your state or natural resources department.

Use it Yourself —Like in the Garden or Eat it!

You can also use your recycled Christmas tree to enrich your soil by composting it or using the pine needles and boughs to cover your garden bed. Chop the trunk and branches and break your tree down, this will allow you to add some nice insulation to your garden.

Read entire article for more great ideas
 
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