Monday, January 4, 2021

USDA Continues to Move SNAP Participants Forward

 Final Rule increases opportunities for SNAP participants to gain employment.

Press release issued 1.4.21

https://www.usda.gov/media/press-releases/2021/01/04/usda-continues-move-snap-participants-forward

(Washington, D.C., January 4, 2021) – The U.S. Department of Agriculture today announced a final rule enhancing employment and training opportunities for Supplemental Nutrition Assistance Program (SNAP) participants.


SNAP participants have exclusive access to training and support services to help them enter or move up in the workforce through state SNAP Employment and Training (E&T) programs. The final rule makes a wide range of enhancements to these services to empower more SNAP participants to gain the skills, training, or work experience they need to move forward and into work.


“USDA has a long-standing commitment to increasing opportunities for SNAP participants to move towards and into employment. This rule continues USDA’s efforts to connect more SNAP households with the dignity and hope that work provides,” said USDA Deputy Under Secretary for Food, Nutrition and Consumer Services Brandon Lipps.


Background:

In March, USDA published the proposed rule, “Employment and Training Opportunities in the Supplemental Nutrition Assistance Program.” The rule published today finalizes many of those changes—improving E&T programs by ensuring that states use evidence-based strategies to help participants get the skills local employers need most, by requiring the use of case management services for E&T participants, and by allowing E&T funds to be used for subsidized employment and apprenticeships.


Today’s final rule underscores USDA’s commitment to improving SNAP E&T programs, in partnership with states. Each year, USDA provides more than $100 million for states to operate their E&T programs. In addition, if a state invests its own money or outside funding to improve its SNAP E&T programs, the federal government will reimburse the state for 50 percent of those funds. Beyond funding, USDA efforts to support SNAP E&T include:


Hosting the first ever SNAP E&T National Forum. The virtual, three-day conference took place Oct. 13-15 and connected more than 1,500 partners from across the country to share and learn best practices to promote and boost employment among SNAP households through state E&T programs.

Operating SNAP to Skills, which provides states and their partners with coaching and intensive technical support on how to build strong E&T programs. This year, seven states – Oregon, Colorado, Louisiana, Illinois, Kentucky, Pennsylvania, and Rhode Island – joined the 22 other states that have participated in SNAP to Skills since the program was launched in 2015.

Providing training, such as the SNAP E&T State Institutes and Learning Academies, to develop expertise in administering SNAP E&T among individuals, partner organizations, and state agencies across the country.

Issuing more than $6.7 million in SNAP E&T National Partnership Grants in 2020 to help four national nonprofit organizations expand program capacity and develop networks of third-party partners to serve SNAP participants.

USDA’s Food and Nutrition Service administers 15 nutrition assistance programs that leverage American agricultural abundance to ensure children and low-income individuals and families have nutritious food to eat. FNS also co-develops the Dietary Guidelines for Americans, which provide science-based nutrition recommendations and serve as the cornerstone of federal nutrition policy. Follow us on Twitter at @USDANutrition.



(2) FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Press release issued 1.4.21

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-provide-clarity-developing-new-drug-products-age-individualized-medicine


Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.


For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us to pinpoint, in some cases, the exact cause of a patient’s disease. For a patient with a very rare genetic disease, development of a drug product that is tailored to that patient’s specific genetic variant may be possible. This is an important advance in treatment for those with very rare genetic diseases, especially those for which there are no adequate therapies available to treat the disease. Often, these very rare diseases are rapidly progressing, debilitating, and in many cases, can lead to premature death if left untreated.


Developing these products – also referred to as “n of 1” therapies by some because they are designed for a patient population of one person – brings a set of challenges and considerations not seen with the typical drug development process. First, as noted above, the disease is often rapidly progressing, requiring prompt medical intervention. Therefore, development needs to proceed very quickly to have a chance at helping the individual. Second, drug discovery and development for these drug products may be carried out by academic investigators, rather than by biopharmaceutical or pharmaceutical companies. These investigators may be less familiar with FDA’s regulations, policies and practices, and less experienced in interacting with the FDA. 


At this time, development of individualized genetic drug products is most advanced for antisense oligonucleotide (ASO) products. Therefore, we are taking the first steps in bringing clarity to this emerging area of individualized drug development by releasing a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products.  


The guidance was developed to advise those developing ASO products on an approach to interacting with, and making regulatory submissions to, the FDA. The guidance addresses the following points:  


The approach to obtaining feedback from the FDA,

The expectations and process for making regulatory submissions to the FDA,

Recommendations about the requirement for Institutional Review Board (IRB) review of the protocols within, and

How to obtain informed consent.  

As also discussed in a New England Journal of MedicineExternal Link Disclaimer editorial in October 2019, we are fully aware that this new drug-discovery paradigm raises many ethical and societal issues that will need to be addressed throughout the process. For example, in these situations, the individuals and their families often function more like drug development collaborators than traditional trial participants. Therefore, it is important to discuss with the individual and family members how effectiveness will be measured. It is also important to ensure that the individual and family members understand the parameters for continuing administration of the investigational drug product before emotions influence decisions, and to recognize that some investigational drug products may fail, or worse, lead to unforeseen side effects.


The FDA understands that we’ll need to work together with the developers of these drug products to bring them safely to patients, and we are willing to engage as needed to address the challenges. For example, for those developing these drug products, it will be important to further understand the required data and information that must be submitted to the FDA so that clinical testing can begin. The FDA is continuing to consider and further develop policy to address some of these issues.


We also are optimistic that development of these individualized drug products may spur gene sequencing that leads to the development of additional individualized drug products for the same disease (though perhaps caused by a different mutation). For this approach to drug development, we need to determine – collectively – how to effectively bring these drug products to all who need them. If we have the scientific ability to develop drug products for these rare diseases, we need to find a way to bring them to patients while ensuring there is the right balance of risk to benefit. This guidance, which provides clarity on the early development and IND submission process, is the FDA’s first step in working with those who are developing these individualized drug products.



(3) TODAY'S TOP HEADLINE NEWS


WORLD HEADLINES:

UN denounces attacks on villages in western Niger

The United Nations Secretary-General has strongly condemned Saturday’s attack by unidentified gunmen on two villages in western Niger, which reportedly left about one hundred people dead, while hundreds of survivors fled the scene on foot. --UN NEWS CENTER

https://news.un.org/en/story/2021/01/1081322



World Braille Day highlights importance of accessible information.

The United Nations is commemorating World Braille Day on Monday, highlighting the importance of the universal touch-based communication system for the full realization of human rights for blind and partially sighted people. --UN NEWS CENTER

https://news.un.org/en/story/2021/01/1081312



UN condemns back-to-back attacks in Central African Republic 

The UN mission in the Central African Republic (CAR) condemned, in the strongest terms, succeeding assaults launched by armed groups in Damara on Saturday and Bangassou on Sunday.---UN NEWS CENTER

https://news.un.org/en/story/2021/01/1081282



Myanmar Independence Day--State Dept.

https://www.state.gov/myanmar-independence-day/


On behalf of the Government of the United States and the American people, I send best wishes to the people of Myanmar on the occasion of your independence day.


The United States is committed to partnering with the people of Myanmar in support of the country’s democratic transition, national reconciliation, and economic transformation.


We will continue to work with your government, civil society, and youth to help achieve greater peace, prosperity, and freedoms in Myanmar.  May all the people of Myanmar enjoy a healthy and happy new year.




NATIONAL:


President Donald J. Trump to Award the Medal of Freedom to Devin Nunes--WH press release 1.4.21

https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-award-medal-freedom-devin-nunes/



Medal of Honor Monday: Army Staff Sgt. Isadore Jachman--DOD

Thousands of American soldiers who volunteered to fight the Nazis had plenty of reasons to partake in one of the most perilous missions ever fought. But perhaps few had more than Army Staff Sgt. Isadore Jachman — one of three Jewish men to receive the Medal of Honor for actions during World War II. 

https://www.defense.gov/Explore/Features/Story/Article/2457823/medal-of-honor-monday-army-staff-sgt-isadore-jachman/



FBI’s Innocent Images Program Marks 25 Years of Investigating Online Child Exploitation

https://www.fbi.gov/news/stories/innocent-images-program-marks-25-years-122820



(4) IN OTHER HEADLINE NEWS...


Campaign Director: Warnock 'Absolutely' Backs Defunding Police, 'Most of Them Are Bad'--PJ MEDIA

https://pjmedia.com/election/tyler-o-neil/2021/01/04/campaign-director-warnock-absolutely-backs-defunding-police-most-of-them-are-bad-n1303017


Trump Reminded Us What It’s Like to Have an American President--PJ MEDIA

https://pjmedia.com/news-and-politics/robert-spencer/2021/01/03/trump-reminded-us-what-its-like-to-have-an-american-president-n1301270


God %$@! America, Again?

Georgia's runoff features one particular America-hating radical leftist--Patriot Post

https://patriotpost.us/articles/76753-god-percent-dollars-at-america-again-2021-01-04


Trump's Call With Raffensperger Was 19th Time He Tried to Reach Him--NEWSMAX

https://www.newsmax.com/politics/trump-phone-call-raffensperger/2021/01/04/id/1004128/




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