March 23, 2009 security lapse at entrance to Robinsons Ermita; advisory re Wendy's restaurant at Robinsons Ermita; advisory re Rissa M. Mananquil; etc

Security lapse on March 23, 2009 at entrance to Robinsons Ermita.
Because of said security lapse, I could have brought dangerous weapons into said mall.

Advisory re Wendy's restaurant at Robinsons Ermita
On March 23, 2009, I was at said restaurant. I saw a live moving fly in the dining area of said restaurant.

advisory re Rissa M. Mananquil, Tricks Exfocleanser, L'Oreal skincare line Men's Expert

The following words were published under said Mananquil's name in the March 4, 2009 issue of the Philippine Star newspaper: "I recommend Tricks Exfocleanser", My comments: If people follow said Mananquil's recommendation regarding said product and are not satisfied with said product, will she help them get refunds? "Tricks Exfocleanser is especially formulated for men and effective enough to address your needs in caring for the face." My comments: Did said Mananquil actually witness the formulation of said product? If said product is not effective enough to address said John's needs in caring for the face, will said Mananquil help said John?"Product description explains . . ." My comment: Is said Mananquil naive enough to believe a product description? "Tricks Exfocleanser is dermatologist tested" My comment: Did said Mananquil witness said testing by said alleged dermatologist? "its also enriched with vitamins E, B3, and B5 to nourish the skin." My comment: Does said Mananquil have personal knowledge of said alleged enrichment? "Pimple Clearing (controls breakouts)" My comment: If said product called pimple clearing does not control breakouts, will said Mananquil help customers who may have used said product? "Oil Control (gets rid of excess oil" My comment: If said alleged Oil Control product does not get rid of excess oil, will said Mananquil help customers who may have used said product? "Whitening (lightens skin)" My comment: If said so called Whitening product does not lighten skin will said Mananquil help customers who may have used said product?
Said Mananquil also made the following claims regarding the L'Oreal skincare line Men's Expert: "This , , , skin care line offers . . . with sun
protection." My comment: What, if any, is the basis of said Mananquil's claim that said products have sun protection? " :L'Oreal Men's Expert White
Activ . . . is a moisturizer with UV protection that will help give you clearer and brighter skin."


U.S. Food and Drug Administration Center for Drug Evaluation and Research Office for Nonprescription Products
http://www.fda.gov/cder/offices/OTC/default.htm

What We Do

Over-the-counter (OTC) drug products are those drugs that are available to consumers without a prescription. There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks.

OTC drugs play an increasingly vital role in America's health care system by providing easy access to certain drugs that can be used safely without the help of a health care practitioner. This enables consumers to take control of their own health care in many situations. There are more than 100,000 OTC drug products marketed, encompassing about 800 significant active ingredients.

Most OTC drug products have been marketed for many years, prior to the laws that require proof of safety and effectiveness before marketing. For this reason, FDA has been evaluating the ingredients and labeling of these products as part of "The OTC Drug Review Program." The goal of this program is to establish OTC drug monographs for each class of products.

OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and testing. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval, while those that do not, must undergo separate review and approval through the New Drug Application (NDA) process. The NDA process, and not the monograph process, is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC drug products (previously available only by prescription) are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process.

FDA's review of OTC drugs is primarily handled by CDER's Office of Nonprescription Products. However, scientists and regulators throughout CDER, the Office of General Counsel, and other Centers within FDA are routinely asked to assist in this massive effort. There is also an advisory committee, the "Nonprescription Drug Advisory Committee," which meets regularly to assist the agency in evaluating issues surrounding these products.

Date updated: May 29, 2003



Office of Nonprescription Products
Consumer Information: Safe Use of Over-the-Counter Drug Products
General Information

* Medicines In My Home. An educational program about safe use of OTC medicines.
* Over-the-Counter Medicine. These materials will help you, working with your health care professionals, to choose and use over-the-counter medicine wisely.
* Over-the-Counter Medicine: All graphics and other media. These materials include brochures, pamphlets, public service announcements, and more.
* FDA Consumer Health Information
* Frequently Asked Questions on the Regulatory Process of OTC Drugs
* How FDA Regulates OTC Drugs
* New Drug Development in the U.S.


http://www.fda.gov/cder/drug/infopage/sunscreen/qa.htm#7
Questions and Answers on the 2007 Sunscreen Proposed Rule

1. What is ultraviolet light and why should I be concerned about it?
2. Why is FDA now coming up with ratings for UVA protection provided by sunscreens and how are these ratings different than Sun Protection Factor (SPF) ratings?
3. Is the 1999 rule currently in effect? How does this proposed rule relate to the 1999 final rule?
4. What’s being proposed in this new rule?
5. What does the proposed labeling look like?
6. Why are sunscreens limited to SPFs of “50+?”
7. How will consumers know how much UVA protection a sunscreen provides?
8. Why is FDA proposing symbols and descriptors to identify the level of UVA protection rather than numerals similar to the SPF?
9. Have star ratings for UVA protection been used before?
10. What type of testing is required to demonstrate UVA protection?
11. How long is the comment period and where should I send comments?
12. Can sunscreens prevent skin cancer?
13. What has changed about the sun alert statement and why did we change it?
14. Why is it important to reapply sunscreens frequently?
15. Are sunscreens really “waterproof?”
16. Are sunscreens and “sunblocks” the same thing?
17. I understand that this proposed rule introduces UVA testing. Have any changes been made to the SPF (UVB) test method?
18. Do manufacturers have to comply with the regulations in this proposed rule?
19. When will FDA publish a final rule based on this proposed rule?
20. Sunscreens are considered cosmetics in Europe. Why are sunscreens regulated as drugs in this country?
21. Where can I get more information about sunscreens?



1. What is ultraviolet light and why should I be concerned about it?

The sun produces not only the visible light that we can see but also ultraviolet (UV) light that we can’t see. There are two types of UV light that can be harmful to us: UVA and UVB. UVB light is primarily responsible for causing sunburn. Both UVB and UVA light contribute to skin cancer, premature skin aging, and other types of skin damage. It is important to protect ourselves from both UVB and UVA light.

2. Why is FDA now coming up with ratings for UVA protection provided by sunscreens and how are these ratings different than SPF ratings?

FDA has been concerned about exposure to ultraviolet (UV) light from the sun since the OTC drug review process began over 30 years ago. Until now most of the focus of FDA’s attention has been on reducing exposure to UVB light. Nonetheless, the issue of protecting against exposure to UVA light has been addressed broadly in all previous rulemakings. Currently, there are no internationally accepted standards for evaluating the effectiveness of a sunscreen in protecting against UVA light. In fact, only a few countries have even addressed UVA protection at all. FDA is aware of ten different tests designed to measure UVA protection. Over the last several years, FDA has conducted detailed analyses of data and information related to all of these UVA tests and, in this rule, is proposing a standard testing protocol. The new protocol requires clinical and non-clinical tests to give an accurate and reproducible assessment of UVA protection. Comparable to the SPF test which measures how well a sunscreen reduces burning, the clinical test for UVA effectiveness measures how well a sunscreen reduces darkening of the skin. Based on this test, sunscreens are classified as low, medium, high, or highest UVA protection. The non-clinical test measures the ability of a sunscreen to reduce the amount of UVA light passing through the sunscreen. Based on the non-clinical test, sunscreens are also classified as providing low, medium, high, or highest UVA protection. The results of both tests are combined to produce a single UVA protection level (i.e., low, medium, high, or highest) with a corresponding star rating. The UVA protection level represents the lowest level of protection determined by the two tests. For example, if one test indicates a low level of UVA protection and the other test indicates a medium level of protection, the sunscreen is labeled as having a low level of UVA protection.

The level of UVB sunscreen protection is indicated by a numerical value (e.g., SPF 30). In contrast, the level of UVA protection is indicated by a descriptor with an accompanying star rating (e.g., medium 2 stars - medium). FDA believes the different ways of labeling UVB and UVA protection will minimize potential confusion about the ratings.

3. Is the 1999 rule currently in effect? How does this proposed rule relate to the 1999 final rule?

The 1999 final rule addressed UVB testing and labeling requirements for sunscreen products. That final rule was stayed and is not currently in effect so that the agency could also address UVA testing and labeling requirements for sunscreen products. This proposed rule amends the conditions of the final rule to incorporate these UVA testing and labeling requirements. After consideration of the comments submitted in response to this proposed rule, FDA will then issue a final rule that addresses both the UVA and UVB issues for sunscreen products.

4. What’s being proposed in this new rule?

FDA is proposing to:

* add new combinations of avobenzone and other active ingredients
* include UVA protection effectiveness testing and corresponding labeling
* change the highest SPF values from “30+” to “50+”
* require a revised “sun alert” statement as the first statement in the Drug Facts Warnings section (the original statement was optional)
* place greater emphasis on reapplying sunscreens (to avoid lowering protection)
* make minor revisions to the existing SPF (UVB) testing procedures



5. What does the proposed labeling look like?

For a three-ingredient, very water resistant sunscreen, the principal display panel will look something like this:

sunscreen - proposed label


For a three-ingredient, very water resistant sunscreen, the Drug Facts box will look like this:

Sunsceen - Proposed Drug Facts

6. Why are sunscreens limited to Sun Protection Factors ( SPF) of “50+?”

FDA limits SPF values based on data demonstrating that the SPF test provides accurate and reproducible results. When FDA published the sunscreen final monograph in 1999, FDA had only received data demonstrating that the SPF test produces accurate and reproducible data for sunscreens with SPF values as high as 30. Since publication of the final monograph, FDA has received data indicating that sunscreens with SPF values as high as 50 can be measured accurately and reproducibly using the SPF test. Further, FDA believes that, although we have not yet seen such data, some sunscreens may produce SPF values greater than 50. For such sunscreens, we are allowing an SPF of “50+.” If FDA receives data that support accurate testing of sunscreens higher than 50, we will consider revising the upper limit of SPF permitted in labeling.

7. How will consumers know how much UVA protection a sunscreen provides?

FDA is proposing to use symbols (stars) along with descriptors (low, medium, high, or highest) to indicate how much UVA protection a sunscreen provides. Sunscreens providing UVA protection will bear one of the following configurations:
Star Category

Category Descriptor
sunscreen 1 star low

Low
sunscreen category: 2 stars medium

Medium
sunscreen category: 3 stars high

High
sunscreen category: 4 stars highest

Highest

So a sunscreen providing medium UVA protection may be labeled like this:

UVA
sunscreen category: 2 stars medium
Medium

If a sunscreen hasn’t been shown to provide any UVA protection, FDA proposes that the sunscreen contain the statement “No UVA Protection” near the SPF value.



8. Why is FDA proposing symbols and descriptors to identify the level of UVA protection rather than numerals similar to the SPF?

Because SPF values have been used in the United States for more than three decades, consumers are familiar with SPF numbers and know how to select the appropriate sunscreen based on the SPF value. Therefore, FDA does not believe the SPF numerical values should be changed. However, FDA believes consumers might be confused if UVB and UVA protection levels were both identified by numbers. Having distinct ways of identifying UVB and UVA protection levels should make it less likely that consumers will confuse the two ratings. Although the symbol and descriptor rating of UVA protection is new, FDA expects consumers will learn how to use this information to select the appropriate sunscreen, as they have done with SPF values. FDA believes consumers are familiar with star rating because they are used to rate the quality of a variety of topics (e.g., movies, hotels, and restaurants).

9. Have star ratings for UVA protection been used before?

Yes. In January 1992, the Boots Co. in the United Kingdom developed a star rating system to characterize UVA protection. Protection ratings range from “minimum” (one star) to “ultra” (five stars). In addition, although star ratings have not previously been used in the Unites States to rate UVA protection levels, they have been used extensively to rate many industries (e.g., movies, hotels, and restaurants).

10. What type of testing is required to demonstrate UVA protection?

Two separate tests must be conducted to demonstrate that a sunscreen helps provide protection against UVA light. One of these is an in vitro test (performed on a quartz plate) and the other is an in vivo test (performed on humans). The results of both tests are combined to produce a single UVA protection level (i.e., low, medium, high, or highest). The UVA protection level represents the lowest level of protection determined by the two tests. For example, if one test indicates a low level of UVA protection and the other test indicates a medium level of protection, the sunscreen is labeled as having a low level of UVA protection.

The in vitro test is a non-clinical test, meaning it is performed in a laboratory and not on humans. This test measures the ability of a sunscreen to reduce the amount of UVA radiation passing through the sunscreen. The in vivo test is performed on humans and is similar to the SPF test. The major difference between this test and the SPF test is that sunburn is measured in the SPF test and skin darkening is measured in this test.

11. How long is the comment period and where should I send comments?

Before finalizing any monograph, FDA allows the public to share its views (comments) on the proposed regulations. For most of the issues in this proposed rule, FDA is accepting comments for 90 days from the date the proposed rule published.

Comments must be identified with “Docket No. 1978N-0038” and can be submitted electronically or in written form:

Electronic submissions

* Federal eRulemaking Portal: http://www.regulations.gov
* FDA web site: http://www.fda.gov/dockets/ecomments

Written submissions

* FAX: 301-827-6870
* Mail/Hand Delivery/Courier:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852



12. Can sunscreens prevent skin cancer?

FDA doesn’t have any data directly linking the use of sunscreens to a reduction in the risk of developing skin cancer. Research has shown that UV exposure increases skin cancer, premature skin aging (e.g., wrinkles), and other skin damage (e.g., sunburn). Although studies have shown that limiting time in the sun, wearing protective clothing, and using sunscreens decrease UV exposure, studies have not specifically linked the use of sunscreen by itself to reduced risk of skin cancer or skin aging. To the contrary, studies have shown that some consumers increase time in the sun when wearing sunscreens, thereby increasing UV exposure. Thus, in this proposed rule, FDA proposes that the following statement be required in the Warnings section of the Drug Facts box:

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

13. What has changed about the sun alert statement and why did we change it?

The sun alert statement used to be optional and, if included, appeared in the Other information section of the Drug Facts box or outside the Drug Facts box altogether. The statement read, “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.” FDA now proposes to require a modified version of the sun alert statement be included as the first statement under Warnings in the Drug Facts box. The new statement reads:

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

14. Why is it important to reapply sunscreens frequently?

There are three reasons why sunscreens should be reapplied frequently. First, sunscreens can be physically rubbed off. For example, drying off with a towel can remove sunscreen from the skin. Second, sunscreens can be washed off when swimming or with heavy sweating. No sunscreens are truly “waterproof” or “sweatproof.” Third, some of the active ingredients in sunscreens start to break down over time. This break down can be accelerated by sun exposure. These three factors can prevent sunscreens from providing the level of protection indicated by the SPF and or UVA values. Thus, to ensure that sunscreens provide effective prevention, FDA proposes that sunscreens include the following directions:

* For sunscreens that are not water resistant:
o “Reapply at least every 2 hours and after towel drying, swimming, or sweating”
* For sunscreens that are water resistant:
o “Reapply after 40 minutes of swimming or sweating, and after towel drying. Otherwise, reapply at least every 2 hours."

15. Are sunscreens really “waterproof?”

No. FDA has determined that sunscreens are neither sweatproof nor waterproof. Most sunscreen formulations don’t dissolve in water (or sweat), but can be washed off during swimming and as a consequence of sweating. Thus, FDA does allow claims that sunscreens are water resistant or water/sweat resistant if the sunscreens retain the label SPF and /or UVA protection values following 40 minutes of water immersion. Sunscreens that retain the label SPF and/or UVA protection values after 80 minutes of water immersion can be identified as “very water resistant” or “very water/sweat resistant.”

You may see sunscreen products marketed as “waterproof” or “sweatproof.” FDA does not believe that these are accurate statements and explained this position in both the tentative final monograph published in 1993 and the final monograph published in 1999. When FDA publishes a sunscreen final rule that includes both UVB and UVA testing and labeling requirements, manufacturers will be required to amend these claims.

16. Are sunscreens and “sunblocks” the same thing?

FDA does not believe the term “sunblock” is accurate. No sunscreen completely blocks UV rays. FDA believes the term “sunscreen” more accurately describes the action of this type of drug product.



17. Have any changes been made to the SPF (UVB) test method?

Yes. FDA is proposing changes to the SPF test method. FDA believes these changes will decrease the health risk to persons enrolled in the SPF test. The changes also should lead to more accurate and reproducible results. The changes will not alter how consumers compare sunscreens with different SPF values to select the appropriate product. The changes will only alter how manufacturers determine the SPF values of these products.

18. Do manufacturers have to comply with the regulations in this proposed rule?

When the final rule is published, manufacturers will be required to comply with sunscreen regulations. Until then, FDA strongly encourages manufacturers to comply with this proposed rule. We believe that compliance with this proposed rule is in the best interests of public health. Nonetheless, manufacturers are not required to comply with the proposed regulations until FDA publishes a final rule

19. When will FDA publish a final rule based on this proposed rule?

Following publication of this proposed rule in the Federal Register, there is a 90-day comment period allowing any interested parties to recommend changes to the proposed rule. After the comment period ends, FDA will review all of the submitted data and information. FDA will then issue a final rule for OTC sunscreens, which will take effect on a date specified in the final rule. After that date all OTC sunscreen manufacturers must comply with the final rule. FDA will work as quickly as possible to draft the final rule.

20. Sunscreens are considered cosmetics in Europe. Why are sunscreens regulated as drugs in this country?

This issue was addressed in the 1999 sunscreen final rule (Federal Register, vol. 64, pages 27668 – 27669). In that document, we noted that because sunscreen active ingredients “affect the structure and function of the body by absorbing, reflecting, or scattering the harmful, burning rays of the sun,” sunscreen products intended for such use are regulated as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(g)(1)). Although the European Commission classifies sunscreens as cosmetics, sunscreens in Europe must meet standards for safety and effectiveness comparable to the sunscreen (drug) standards that exist in the United States.

21. Where can I get more information about sunscreens?

Visit FDA’s website for nonprescription drug products: http://www.fda.gov/cder/Offices/OTC/consumer.htm


http://www.fda.gov/cder/Offices/OTC/understanding_spf_sunscreen.htm
Sunburn Protection Factor (SPF)

SPF is a measure of how much solar energy (UV radiation) is required to produce sunburn on protected skin (i.e., in the presence of sunscreen) relative to the amount of solar energy required to produce sunburn on unprotected skin. As the SPF value increases, sunburn protection increases.

There is a popular misconception that SPF relates to time of solar exposure. For example, many consumers believe that, if they normally get sunburn in one hour, then an SPF 15 sunscreen allows them to stay in the sun 15 hours (i.e., 15 times longer) without getting sunburn. This is not true because SPF is not directly related to time of solar exposure but to amount of solar exposure. Although solar energy amount is related to solar exposure time, there are other factors that impact the amount of solar energy. For example, the intensity of the solar energy impacts the amount. The following exposures may result in the same amount of solar energy:

* one hour at 9:00 a.m.
* 15 minutes at 1:00 p.m.

Generally, it takes less time to be exposed to the same amount of solar energy at midday compared to early morning or late evening because the sun is more intense at midday relative to the other times. Solar intensity is also related to geographic location, with greater solar intensity occurring at lower latitudes. Because clouds absorb solar energy, solar intensity is generally greater on clear days than cloudy days.

In addition to solar intensity, there are a number of other factor that influence the amount of solar energy that a consumer is exposed to:

* skin type
* amount of sunscreen applied
* reapplication frequency

Fair-skinned consumers are likely to absorb more solar energy than dark-skinned consumers under the same conditions. The amount of sunscreen applied also impacts the amount of solar radiation absorbed, because more sunscreen results in less solar energy absorption. Because sunscreens wear off and become less effective with time, the frequency with which they are reapplied is critical to limiting absorption of solar radiation. The reapplication frequency is also impacted by the activities that consumers are involved in. For example, consumers who swim while wearing sunscreen need to reapply the sunscreen more frequently because water may wash the sunscreen from the body. In addition, high levels of physical activity require more frequent reapplication because the activity may physically rub off the sunscreen and heavy sweating may wash off the sunscreen. In general, more frequent reapplication is associated with decreased absorption of solar radiation.

Because of the various factors that impact the amount of solar radiation, SPF does not reflect time in the sun. In other words, SPF does not inform consumers about the time that can be spent in the sun without getting sunburn. Rather, SPF is a relative measure of the amount of sunburn protection provided by sunscreens. It allows consumers to compare the level of sunburn protection provided by different sunscreens. For example, consumers know that SPF 30 sunscreens provide more sunburn protection than SPF 8 sunscreens.



NINDS Traumatic Brain Injury Information Page
http://www.ninds.nih.gov/disorders/tbi/tbi.htm

Synonym(s): Head Injury, Brain Injury
Condensed from Traumatic Brain Injury: Hope Through Research

Table of Contents
What is Traumatic Brain Injury?
Is there any treatment?
What is the prognosis?
What research is being done?
Clinical Trials
Organizations
Related NINDS Publications and Information
Publicaciones en Español
Additional resources from MEDLINEplus

What is Traumatic Brain Injury?

Traumatic brain injury (TBI), also called acquired brain injury or simply head injury, occurs when a sudden trauma causes damage to the brain. TBI can result when the head suddenly and violently hits an object, or when an object pierces the skull and enters brain tissue. Symptoms of a TBI can be mild, moderate, or severe, depending on the extent of the damage to the brain. A person with a mild TBI may remain conscious or may experience a loss of consciousness for a few seconds or minutes. Other symptoms of mild TBI include headache, confusion, lightheadedness, dizziness, blurred vision or tired eyes, ringing in the ears, bad taste in the mouth, fatigue or lethargy, a change in sleep patterns, behavioral or mood changes, and trouble with memory, concentration, attention, or thinking. A person with a moderate or severe TBI may show these same symptoms, but may also have a headache that gets worse or does not go away, repeated vomiting or nausea, convulsions or seizures, an inability to awaken from sleep, dilation of one or both pupils of the eyes, slurred speech, weakness or numbness in the extremities, loss of coordination, and increased confusion, restlessness, or agitation.

Is there any treatment?

Anyone with signs of moderate or severe TBI should receive medical attention as soon as possible. Because little can be done to reverse the initial brain damage caused by trauma, medical personnel try to stabilize an individual with TBI and focus on preventing further injury. Primary concerns include insuring proper oxygen supply to the brain and the rest of the body, maintaining adequate blood flow, and controlling blood pressure. Imaging tests help in determining the diagnosis and prognosis of a TBI patient. Patients with mild to moderate injuries may receive skull and neck X-rays to check for bone fractures or spinal instability. For moderate to severe cases, the imaging test is a computed tomography (CT) scan. Moderately to severely injured patients receive rehabilitation that involves individually tailored treatment programs in the areas of physical therapy, occupational therapy, speech/language therapy, physiatry (physical medicine), psychology/psychiatry, and social support.
What is the prognosis?

Approximately half of severely head-injured patients will need surgery to remove or repair hematomas (ruptured blood vessels) or contusions (bruised brain tissue). Disabilities resulting from a TBI depend upon the severity of the injury, the location of the injury, and the age and general health of the individual. Some common disabilities include problems with cognition (thinking, memory, and reasoning), sensory processing (sight, hearing, touch, taste, and smell), communication (expression and understanding), and behavior or mental health (depression, anxiety, personality changes, aggression, acting out, and social inappropriateness). More serious head injuries may result in stupor, an unresponsive state, but one in which an individual can be aroused briefly by a strong stimulus, such as sharp pain; coma, a state in which an individual is totally unconscious, unresponsive, unaware, and unarousable; vegetative state, in which an individual is unconscious and unaware of his or her surroundings, but continues to have a sleep-wake cycle and periods of alertness; and a persistent vegetative state (PVS), in which an individual stays in a vegetative state for more than a month.
What research is being done?

The National Institute of Neurological Disorders and Stroke (NINDS) conducts TBI research in its laboratories at the National Institutes of Health (NIH) and also supports TBI research through grants to major medical institutions across the country. This research involves studies in the laboratory and in clinical settings to better understand TBI and the biological mechanisms underlying damage to the brain. This research will allow scientists to develop strategies and interventions to limit the primary and secondary brain damage that occurs within days of a head trauma, and to devise therapies to treat brain injury and improve long-term recovery of function.

More information about Traumatic Brain Injury (TBI) Research is available at http://www.ninds.nih.gov/research/tbi/index.htm


Organizations
Acoustic Neuroma Association
600 Peachtree Parkway
Suite 108
Cumming, GA 30041
info@anausa.org
http://www.anausa.org
Tel: 770-205-8211 877-200-8211
Fax: 770-205-0239/877-202-0239

Brain Injury Association of America, Inc.
1608 Spring Hill Rd
Suite 110
Vienna, VA 22182
braininjuryinfo@biausa.org
http://www.biausa.org
Tel: 703-761-0750 800-444-6443
Fax: 703-761-0755

Brain Trauma Foundation
523 East 72nd Street
8th Floor
New York, NY 10021
http://www.braintrauma.org
Tel: 212-772-0608
Fax: 212-772-0357

Family Caregiver Alliance/ National Center on Caregiving
180 Montgomery Street
Suite 1100
San Francisco, CA 94104
info@caregiver.org
http://www.caregiver.org
Tel: 415-434-3388 800-445-8106
Fax: 415-434-3508

National Rehabilitation Information Center (NARIC)
4200 Forbes Boulevard
Suite 202
Lanham, MD 20706-4829
naricinfo@heitechservices.com
http://www.naric.com
Tel: 301-459-5900/301-459-5984 (TTY) 800-346-2742
Fax: 301-562-2401

National Stroke Association
9707 East Easter Lane
Suite B
Centennial, CO 80112-3747
info@stroke.org
http://www.stroke.org
Tel: 303-649-9299 800-STROKES (787-6537)
Fax: 303-649-1328

National Institute on Disability and Rehabilitation Research (NIDRR)
U.S. Department of Education Office of Special Education and Rehabilitative Services
400 Maryland Ave., S.W.
Washington, DC 20202-7100
http://www.ed.gov/about/offices/list/osers/nidrr
Tel: 202-245-7460 202-245-7316 (TTY)


Related NINDS Publications and Information

* Traumatic Brain Injury: Hope Through Research
A booklet about traumatic brain injury (TBI), or head injury, prepared by the National Institute of Neurological Disorders and Stroke (NINDS).
*
Clinical Trials in Head Injury
Summary of a workshop, Clinical Trials in Head Injury, held May 12 and 13, 2000
*
NINDS Shaken Baby Syndrome Information Page
Shaken baby syndrome information sheet compiled by the National Institute of Neurological Disorders and Stroke (NINDS).

Publicaciones en Español

* El Traumatismo Cerebral: Esperanza en la Investigación



Prepared by:
Office of Communications and Public Liaison
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Bethesda, MD 20892


NINDS health-related material is provided for information purposes only and does not necessarily represent endorsement by or an official position of the National Institute of Neurological Disorders and Stroke or any other Federal agency. Advice on the treatment or care of an individual patient should be obtained through consultation with a physician who has examined that patient or is familiar with that patient's medical history.

All NINDS-prepared information is in the public domain and may be freely copied. Credit to the NINDS or the NIH is appreciated.

Last updated December 30, 2008


http://www.cdc.gov/ncipc/tbi/TBI.htm
National Center for Injury Prevention and Control
What is Traumatic Brain Injury?

A traumatic brain injury (TBI) is caused by a blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain. Not all blows or jolts to the head result in a TBI. The severity of a TBI may range from “mild,” i.e., a brief change in mental status or consciousness to “severe,” i.e., an extended period of unconsciousness or amnesia after the injury.




How many people have TBI?

TBIs contribute to a substantial number of deaths and cases of permanent disability annually.

Of the 1.4 million who sustain a TBI each year in the United States:

* 50,000 die;
* 235,000 are hospitalized; and
* 1.1 million are treated and released from an emergency department.1

Among children ages 0 to 14 years, TBI results in an estimated:

* 2,685 deaths;
* 37,000 hospitalizations; and
* 435,000 emergency department visits annually.1

The number of people with TBI who are not seen in an emergency department or who receive no care is unknown.

For more information about TBI in the United States, including the groups at highest risk, CDC’s surveillance activities, and the numbers of TBI cases in each state, see Overview.
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What causes TBI?

The leading causes of TBI are:

* Falls (28%);
* Motor vehicle-traffic crashes (20%);
* Struck by/against events (19%); and
* Assaults (11%).1

For more information on the leading causes of TBI, see Causes.


What are the signs and symptoms of TBI?

The signs and symptoms of a traumatic brain injury (TBI) can be subtle. Symptoms of a TBI may not appear until days or weeks following the injury or may even be missed as people may look fine even though they may act or feel differently.

For a list of common signs and symptoms of TBI, see Signs and Symptoms.


What are the long-term outcomes of TBI?

CDC estimates that at least 5.3 million Americans, approximately 2% of the U.S. population, currently have a long-term or lifelong need for help to perform activities of daily living as a result of a TBI.2

TBI can cause a wide range of functional changes affecting thinking, sensation, language, and/or emotions. It can also cause epilepsy and increase the risk for conditions such as Alzheimer’s disease, Parkinson’s disease, and other brain disorders that become more prevalent with age.3

To learn more about the potential outcomes of TBI, see Outcomes.


What are the costs of TBI?

Direct medical costs and indirect costs such as lost productivity of TBI totaled an estimated $60 billion in the United States in 2000.4

References

1. Langlois JA, Rutland-Brown W, Thomas KE. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. Atlanta (GA): Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2004.


2. Thurman D, Alverson C, Dunn K, Guerrero J, Sniezek J. Traumatic brain injury in the United States: a public health perspective. Journal of Head Trauma and Rehabilitation 1999;14(6):602–15.


3. National Institute of Neurological Disorders and Stroke. Traumatic brain injury: hope through research. Bethesda (MD): National Institutes of Health; 2002 Feb. NIH Publication No.: 02–158.


4. Finkelstein E, Corso P, Miller T and associates. The Incidence and Economic Burden of Injuries in the United States. New York (NY): Oxford University Press; 2006.




Contact
Information

National Center for Injury Prevention and Control
Mailstop F41
4770 Buford Highway NE
Atlanta, GA 30341-3724

Phone: 1-800-CDC-INFO
(1-800-232-4636)
Email: cdcinfo@cdc.gov



This page last modified on March 18, 2009.

Centers for Disease Control and Prevention
National Center for Injury Prevention and Control