FDA plans to improve O-T-C Drug Process

Update 1-28-2015: Over-The-Counter Drug Monograph System—Past, Present, and Future; Public Hearing and The Future: Modernizing the OTC Drug Review

The Food & Drug Administration (FDA) will host comments from the public March 25th & 26th regarding any suggestions to improve/expedite the process of approving or changing the label warnings on over-the-counter (OTC) “monograph” drugs. Monograph here is defined as drugs which have a “non-proprietary” list of ingredients to formulate which are available to many manufacturers.

The FDA hopes to approve more competitive drugs and devices faster to offer better economic choices for consumers. And at the same time, if problems arise like the acetaminophen issue linked with liver toxicity, they look to implement label safety warnings faster.

Note: My concern is that they don’t get outside pressure and will give enough time to determine if there are safety issues before they approve a product that could have been teted a little more.

Source: WSJ, 2-22/23-2014, A3.

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Red Light Cameras

Do they just provide revenue to local communities (back door taxes), or just invasive to your privacy, or cause more rear end accidents than prevent?

Or like in Chicago, home of President Obama, it was a money maker for a corrupt public official. Mayor Rahm Emanuel admitted he had no oversight rules before but now after the act, initiated some oversight…

Yes…

Alternatives could be to post flashing and/or large warning signs that you are approaching a dangerous intersection…and if you are too drunk or too stupid or both to slow down – you can kill someone else except your inconsiderate worthless self!

There, that about says it all…any more can be found in the Wall Street Journal article on Page A2 of the February 27, 2014 issue.

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Landmark property tax bill legality issue

8-26-2014 Update: Supreme Judicial Court in Massachusetts rules conservation lands are tax exempt.

The New England Forestry Foundation refused to pay their property taxes (<$200) for 120 acres of land and trees. They claimed they should be exempted of property taxes because their property satisfied a state law which exempts taxes if property provides a public good by preserving nature. (No, not available for normal resident if you fail to mow your grass and claim preservation - sorry.) Main question: Does vacant land provide a benefit to the community? The outcome of this case could set precedence across the country on how many other land trusts with large land tracts or organizations pay property taxes. Source: WSJ, 2-5-2014, A3 References to information, products, and/or services are not a specific endorsement, but the user must perform their due diligence and investigate whether the information, product, or service is right for them. I welcome any or all comments that would help others.

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Overview of Contracts for Distressed Properties

This summary is based on limited information at this time, but at least informative and offers caveats to property buyers of distressed properties. This post will be updated as I learn more about the contract stipulation and measures of protection for both the financial institutions and the consumer.

Normally, a contract will provide for seller to transfer property under a General Warranty (a General promise to help “defend” or stand behind a legitimate title transfer); make certain guarantees and disclosures of condition; provide for a period of time for Buyer to perform inspections and a period of time to negotiate any repairs; obtain copies of surveys (if applicable); and generally hold themselves out for possible lawsuit if they have committed any fraudulent act or made false claims that were proven to defraud the Buyer based on the conditions of the property.

If the property is a short sale or foreclosure being handled by the bank, Fannie Mae, or Freddie Mac, then the contract may have several different provisions such as:

(1) Due Diligence Period: During a period of time referred to as the “Due Diligence” period, the Buyer is allowed a specific number of days to perform an inspection and will normally receive the option of proceeding with the purchase, or terminating the contract on or before this Due Diligence period expires and if terminated, still get their earnest money back.

(2) Property Condition: Under a non-distressed purchase, chances are the property owner has performed an acceptable level of property maintenance, all systems are working as they should, and the Buyer would not need to make many major repairs or changes to the property and it’s in a “move in” condition. Distressed properties may not have received the maintenance or repair attention from either the former owners or the bank who acquired the property. Both functional repairs and cosmetic changes may be required, but the bank will not agree to perform any repairs or maintenance on the property. o are essentially told the property is old “as-is”, or in it’s current condition and no better.

(3) No warranties or representations of conditions:

(a) Physical: Basically, this is where the bank attempts to legally wash their hands of any liability or responsibility of defect or faulty systems or any conditions that were faulty and the Buyer assumes all responsibility to have the home inspected. Buyer Beware – the bank doesn’t care!

(b) Title: The bank will make NO claim that title is clean or clear or stand behind any form of General Warranty where they will stand behind you to defend the legitimacy of title – their response – That’s what owner’s title insurance is for – we still don’t care! (Note: This is the importance of the title search and title insurance – which will even help add protection to Buyer after closing in case of valid liens found after closing.

(c) No home warranty of any form (even from an independent home warranty provider – see my previous blog post on Home Warranties) will be allowed to be paid for before, during, or after closing by the bank or Buyer. (Note: The Buyer can purchase one on the side if they wish, but the purchase is not allowed on the new HUD-1 Settlement Statement.)

(4) Hold Harmless: In other word, you the Buyer won’t take any legal action or sue the bank or any of its representatives in the future for anything that happens after closing including property damage, liens from previous contractors or other entities.

(5) Toxic Sheetrock: In the mid 2000’s due to skyrocketing residential development and demand exceeding supply of US sheetrock, some sheetrock was imported from China and other areas of the world that had synthetic gypsum and causes health or other problems to HVAC systems. Normally banks want to eliminate any legal action you may take after discovering existence of faulty sheetrock.

(6) Various contingencies for Buyer and Seller including, but not limited to:

(a) Seller is unable to transfer clean title to Buyer;
(b) Hidden legitimate liens that would result in a loss to selling bank;
(c) mortgage insurance claim will not be paid;
(d) previous owner exercises right of redemption;
(e) outstanding hazard insurance claim;
(f) a third party exercises their right of first refusal;
(g) Buyer is former owner of the short-sale/foreclosed property.

(7) Personal property: Items normally movable including kitchen refrigerator, furniture, detached shelving units, standing light fixtures, etc,. are usually excluded from the contract.

(8) Form of Title transfer: Normally, the bank will use a Special Warranty Deed and may use a Quit Claim form to transfer limited title – “If they own it, they transfer title to Buyer at closing”. Since the bank is basically telling you they transfer any ownership they may have, but will not help you defend the legitimacy of the title after closing. Therefore, it is imperative that you obtain adequate “owner’s” title insurance protection at closing.

(9) Property sale contingent on sale of another property? NO! In fact, the bank will prefer cash sale over Buyer financing, maybe even at a lower price.

(10) Occupancy-repairs-changes to property prior to closing? – NEVER! Don’t even think about leaving any personal belongings in the home before closing.

(11) Closing date delay: If there is a delay in closing date caused solely by the Buyer but not lender or Seller, there is normally a penalty fee of $100/day of delay.

(12) Survey: The ole responsibility of the Buyer – on a normal exiting residential property on a lot than 5 acres, nobody requires a survey. The decision to obtain a survey is normally the responsibility of the Buyer – totally their choice.

(12) Back-up offer “gotch-ya”: Some bank contract addendums have a contingency that the property will continue to be marketed and if a better or another acceptable offer (i.e., one without any contingencies) is received and agreed to, then the bank may give the first Buyer a number of days to satisfy those contingencies or terminate the contract. A little underhanded or sneaky if you ask me, but that’s the bank’s rule – not mine.

References to information, products, and/or services are not a specific endorsement, but the user must perform their due diligence and investigate whether the information, product, or service is right for them. I welcome any or all comments that would help others.

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Home Equity – Line of Credit

6-1-2014: According to a recent Wall Street Journal article, in areas of rising prices, HELOCs are rising as well. This time maybe to people with good credit and in areas of rising home prices, not just anywhere. But are people actually putting this additional loan into the home, or buying children’s college tuition, cars, vacations and personal items with the money? Time will tell when another bubble hits.

During the height of the real estate boom of the mid 2000’s, these HELOCS as they are called, allowed people to borrow against their remaining home equity within the first 10 years and pay it back over the subsequent 20 years.

With the number of homeowners who took advantage of these loans to either improve their homes or buy cars, college tuition, vacations, etc…about $210 Billion are coming due in the next 4 years.

So far so good, right? Well, yes if (a) homeowners can afford the payments and (b) interest rates don’t rise too fast as the loans are normally adjustable rates and can rise faster than they can afford to pay.

Now here’s the US Government to the rescue as the Office of the Controller of Currency (OCC) is now asking lenders to make plans to help homeowners refinance into lower interest rate loans.

Will the government save us?

Will this be the next crisis?

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EB-5 Visas for Non-US Job Creators in the US

Update 4-15-2016: A complaint filed in federal court Tuesday alleges that the owner and chief executive of a proposed Vermont ski resort “systematically looted” more than $50 million raised from dozens of foreign investors in what the agency called a Ponzi-like scheme. My question: So, are they going to pull the investor green cards?

Update 4-15-2016: It is estimated that over 18,000 EB-5 Visas will be requested…It seems that the bulk of the projects completed are in more affluent areas, even thought the program was designed to renovate blighted areas…but the dirty little secret – municipalities are connecting poor areas to affluent areas to qualify the affluent area to be enhanced first…and some developers are getting low interest loans which save them millions of dollars. Source: WSJ, 4-13-2016,C8.

Update 12-10-2014: Approximatey 11,000 foreign investors are taking advantage of this law – getting their green cards the old fashioned Chicago way – payoffs!

Well, if you thought it didn’t get silly enough, let’s screw the Americans struggling to build or start a business and the owners and give visas to those outside the US to start a business and employ people here…regardless if they are citizens who are employed.

Hey, if starting a business in the US an be offered to foreigners, why aren’t US citizens breaking the door down to start a business? Answer: Besides the program having fraud and mismanagement (which is no reason to change things under this administration), because the US Government is making it harder to start a business by a US citizen.

And the EB-5 program gives foreign business owners a foothold in the US based on two factors:

(1) Investing at least $500,000 (not sure if their money or may include a US commercial loan). Heck: that’s one decent fast food franchise owned by a foreigner not a US citizen; and

(2) The business must employ at least 10 people in the first two years of operation (that’s a long time and I don’t know if it means all 10+ must be US citizens).

If both criteria above are met, then the temporary EB-5 visa can be converted to a permanent Visa/Green Card.

But who are we kidding – are these visas really that necessary since

It appears that about 3,700 of the 6,4000 (about 57%) applicants were approved for EB-5 visas

Source: WSJ, 1-21-2014, A3

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Recycling in Cobb County

11-6-2014: Smyrna Recycling Center at 645 Smyrna Hill Drive in Smyrna plans to accept recyclables including cooking and motor oils in containers on certain days.

With the exception of the Roswell Recycling center in Alpharetta at bottom of page, this is my first stab at listing potential recycling in Cobb County. This post should be updated when I learn of other recycling efforts.

I specifically want to call attention to the “Keep Cobb Beautiful” organizational effort, supported by many volunteers, to Keep Cobb Clean.

MISCELLANEOUS ITEMS RECYCLED

Click here for locations that accept the following recyclable items:

  • Recycling Information:
  • Aluminum & Tin Cans
  • Batteries – Automotive
  • Batteries – Rechargeable
  • CFL Light bulbs
  • Cell Phones
  • Electronics Glass
  • Ink Jet Cartridges
  • Junk Mail
  • Magazines / Newspapers
  • Office Paper
  • Plastic Bags Plastic Containers
  • Phone Books
  • Rechargeable Batteries
  • Styrofoam
  • Televisions
  • Video Tapes

KEEP COBB BEAUTIFUL:

Keep Cobb Beautiful (KCB) sponsors several recycling programs including but not limited to pharmaceutical disposals, electronics recycling, document shredding.

KCB is also partnering with Advanced Disposal Service locations to offer Cobb residents free drop spots to bring recyclables from home. Items Accepted: Mixed Paper, Plastics (1-7), Aluminum, Steel Cans and Flattened Cardboard.
GLASS WILL NOT BE ACCEPTED

HOUSEHOLD BATTERIES:

Recycled at local Cobb County Library locations – information here

RECHARGEABLE BATTERIES:

Recycled at local Cobb County Library locations – information here.

Home Depot and Lowes accepts rechargeable batteries from power tools.

CHRISTMAS TREES:

Usually Home Depot accepts trees at many of their store parking lots. If you can’t transport the tee there, they may know people who can pick them up from your curb site…but chances are it won’t get picked up or else everyone would do that and not drop them off.

DEEP FRYER COOKING OIL:

Where do you dispose of the oil from cooking turkeys in deep fryers?

Besides contacting a local Chic-Fil-A restaurant (like the one at 2550 Sandy Plains Road, Marietta, GA 30066 that collects the used oil…

The City Of Smyrna Recycling Education Center

645 Smyrna Hill Drive
(770) 431-2869
(Smyrna Hill Drive is located 1 block south of Concord Road on South Cobb Drive.)
Hours: 8:00 a.m. – 4:00 p.m. Tues., Wed., Fri., and Sat.;
12 p.m. – 8:00p.m. Thurs.
Closed: Sun. and Mon.

Roswell Recycling Center (located at 11570 Maxwell Road, Alpharetta 30009) accepts vegetable oil for recycling.

Auto or light truck tires can be recycled at auto repair facilities that sell tires, but there usually is a nominal $2-5/tire charge. Tires may be disposed of for a fee at the Advanced Disposal Transfer Station located at 1897 County Services Parkway, Marietta, GA 30008. Contact ADS at (770) 485-8940 if you have any questions concerning the recycling of tires.

References to products and services are not a specific endorsement, but the user must perform their due diligence and investigate whether the product or service is right for them. I welcome any or all comments that would help others.

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Obamacare – Doorway to single payer (Government) Insurer

2-26-2014: Government security experts fear State run computer systems connected with Obamacare will become compromised by hackers. Source: MDJ, 2-26-2014, 3A. (Note: We all know that eventually, all systems will probably be hacked, but we will probably spend billions more $ chasing security issues we shouldn’t have started…and that doesn’t count the billion$ spent by consumers to correct their breached personal information and identity theft.)

Don’t like the way it was forced on us from Federal Government, but that’s the agenda toward single payer-provider (i.e., Government managed) healthcare industry which will drive costs up and quality of care down.

I think if left alone or given standards to shoot for, each US state could design something to unite their citizens on plans that would have generated from the ground up, not top down which never works…no matter how much of our money gets thrown at it….especially about $700 Million toward just advertising of healthcare.gov.

Here is a simple list of some continuing problems (more problem will be added to it as I learn them):

  • Health insurance orphans: Those who the government claims are enrolled but the insurer has yet to receive insured enrollment information…so they can’t be processed to receive health are coverage.
  • Duplicate identification # for different enrollees.
  • Gov’t failed to install software sort of enrollees so insurer has to “manually” check all insured names to ensure coverage and this takes time and money…money sure to be passed on in higher insurance rates next year.
  • Fewer young people, one of the primary groups of expected supporters who were the basic expected buyers of these exchanges, haven’t signed up to support insurer revenues and probably will drive exchange premiums even higher.
  • Wal-Mart insurance plans beat healthcare.gov insurance plans on a comparative basis – and they’re cheaper at Wal-Mart!

Come on America – we can do better than to slough off healthcare to an entity (i.e., Federal Government) who does one job real well through its military – brake things and kill people!

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Banks – too weak and fail – but when?

Question now is – Are we letting some weaker banks live longer and risk higher FDIC losses? And if so, just when do we close them to stem FDIC losses?

Office of the Controller of the Currency Main job is to regulate national banks.

They defined Tier 1 capital = Higher quality capital held by the bank to hedge against losses.

Minimum Tier 1 capital by national banks is supposed to be around 3% of total assets, or a total risk based capital ratio 9i.e., overall capital a bank holds to support operations) < 6%. Apparently, current laws don't require regulators to start bank closing procedures unless the ratios fall very low. Source: WSJ, 9-30-2013, C1

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College tuition – is it “currently” worth the rising cost?

A recent article in the January 4-5, 2014 Wall Street Journal on page C1 stated some figures:

  • Almost a 7.5% increase in college tuition costs from 1978-2011.
  • Today’s average student debt is over $29,000
  • 40% of college grads work in jobs they didn’t need college education or training

Parents are beginning to object and college student enrollment is declining.

Will students need to choose more practical degree, cheaper community or 4 year colleges, or skip college and learn a trade?

Will colleges have to prove their effective graduate placement and income performance?

Will all states need to disclose college spending similar to Oregon’s transparency website?

I agree with the conclusion of the article – this rise in tuition costs can’t go on forever – something has to give!

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