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Mark Bittman, in my opinion, is the Godfather of cookbooks. I was so excited to see he had a new cookbook because he's a great teacher to learn from, his recipes are simple, easy, and foolproof, and he brings out the joy in me as a home cook.
Kitchen Matrix is the basic blueprint for cooks to expand upon basic recipes they have mastered. Within the 304 pages there are over 700 recipes based on basic recipes that are mixed in a variety of ways so that you can get more out of one dish. For example, Bittman illustrates 12 ways to use tomatoes in a dish ranging from appetizers such as tomatoes, ricotta cheese, and mint, to fancy tomato soups as the main course. All in which are made with simple, fresh ingredients.
Bittman is a great storyteller which is why I am always enveloped in his headnotes for recipes. I am obsessed with reading the headnotes as much as I am making the recipes because I know there will be a great story from which the recipe originated, and it gives me inspiration for my own recipe development.
The recipes in the Kitchen Matrix covers the usual categories: Drinks, appetizers, soups, sandwiches, meat, vegetables, etc. No dish is left unturned, and Bittman provides you with plenty of options to put a spin on any classic dish.
I enjoyed all the recipes, even those ones where I was unfamiliar with the ingredient. The majority of the recipes are 30 minutes or less to prepare, while there are some they may take up to 1 hour to prepare. The ingredients used in the book are readily available in your home pantry or at your local grocery store.
Overall, I highly recommend buying a copy of Mark Bittman's Kitchen Matrix. It's great for mastering basic dishes as well as inspiration for future dishes.


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Question: Can one simple device be fun, profitable, a source of corporate team building and an antidote to the busy executive`s tendency to get out of touch with customers?
Answer: Yes. The device: the VPI, or volume producing item.
Wal-Mart Stores` growth has been phenomenal, from $50 million a year in sales to close to $7 billion in just 15 years; from 15 to 750 stores in that same period.

subset: commoncrawl


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Evening classes
Traditional (on-campus), hybrid (half online), and online classes offered
Complete in as fast as 20 months
Capstone project: real-world experience
Grants, scholarships, veterans benefits, loans, and undergraduate loan forgiveness are options for paying for this grad degree.
"The HRD program at Nazareth gave me the opportunity to learn from experienced professionals and further develop the critical thinking skills needed to navigate the ever-evolving role of an H.R. professional. Thanks to the program, I have made connections in the H.R. community that I will value my entire career and now feel greater confidence recommending solutions based on the foundation of organizational development intervention strategies."
— Giulia Molisani '12U, '16G, Development and Executive Management at Iberdrola in Madrid, Spain
Education: M.B.A., Syracuse University; M.S. in career & human resource development from Rochester Institute of Technology.
Al has professional management and career development experience from past roles directing internships for the college, working as a career services advisor for Rochester Works!, and serving on the board of the Rochester Career Mentoring Charter School.
Cabral has published and presented at the local and national levels on experiential learning, service learning, internships, and career decision making. He was instrumental in developing the Experiential Education Academy for the National Society for Experiential Education and remains a member of the Academy faculty. In 2010, Cabral received the Outstanding Faculty Advisor award from the National Academic Advisement Association.
Nazareth College is recognized by the Society for Human Resources Management (SHRM) to offer professional development credits (PDCs) for the SHRM-CPSM or SHRM-SCPSM. For more information about certification or recertification, visit www.shrmcertification.org.


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Army Leaflet
After Bowe Bergdahl disappeared, the U.S. Army gave out leaflets in Paktika, initially asking for information about a missing soldier. About two weeks after the Taliban captured Bergdahl, the army distributed fliers like this one.
Our new show, S-Town, is now live! Listen to all 7 chapters →


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from The American Heritage® Dictionary of the English Language, 4th Edition
- n. A soft, steel-gray to black, hexagonally crystallized allotrope of carbon with a metallic luster and a greasy feel, used in lead pencils, lubricants, paints, and coatings, that is fabricated into a variety of forms such as molds, bricks, electrodes, crucibles, and rocket nozzles. Also called black lead, plumbago.
from Wiktionary, Creative Commons Attribution/Share-Alike License
- n. An allotrope of carbon consisting of planes of carbon atoms arranged in hexagonal arrays with the planes stacked loosely that is used as a dry lubricant and in "lead" pencils.
- n. Short for graphite-reinforced plastic, a composite plastic made with graphite fibers noted for light weight strength and stiffness.
- n. A grey colour.
from the GNU version of the Collaborative International Dictionary of English
- n. Native carbon in hexagonal crystals, also foliated or granular massive, of black color and metallic luster, and so soft as to leave a trace on paper. It is used for pencils (improperly called lead pencils), for crucibles, and as a lubricator, etc. Often called plumbago or black lead.
from The Century Dictionary and Cyclopedia
- n. One of the forms under which carbon occurs in nature (see carbon), also known as plumbago and black-lead.
- n. Same as graffito. See the extract.
from WordNet 3.0 Copyright 2006 by Princeton University. All rights reserved.
- n. used as a lubricant and as a moderator in nuclear reactors
from The American Heritage® Dictionary of the English Language, 4th Edition
from Wiktionary, Creative Commons Attribution/Share-Alike License
Liquid graphite is black, slick and somewhat messy, and will require a good cleaning prior to using the rifle.
Less graphite is required in creating the rod blanks, which, according to Whiting, "have the performance of graphite and the durability of fiberglass."
One of the benefits of using graphite is that it keeps the silver from oxidizing, so bullets come out bright and shiny.
While there was always enough money to buy the latest in graphite and Gore-Tex, our wives shopped at discount stores and clad our little ones in hand-me-downs; our oldest kids relied on part-time jobs and student loans to stay in college.
The carbon balls are formed when graphite is evaporated in an inert atmosphere.
Some of the more interesting investigations were conducted on layered compounds, especially on radiation damage in graphite and alkalimetal graphites.
The update is designed for older AirPort Base Stations - the original "graphite" - colored model and its white successor, with dual Ethernet ports.
Some of his famous works include: The School of Athens (fresco) 1511-1512, Christ Supported by Two Angels (1490 – yes, when he was seven!), a self-portrait in graphite (unknown), Coronation of the Virgin (1502-03), and Saint George and the Dragon (unknown).
The problem was that graphite is light, and strong, and very slippery, and none of the scope's little innards would stay anchored, and so it came unglued with the first shot.
CHARLES: They put Scotch tape down on a block of graphite, which is pure carbon.


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What dreamy-eyed boy hasn't looked up at the stars and wanted to see them speeding past at warp? Well now you can! The once-popular screen saver for Microsoft Windows has made a comeback as a live wallpaper for Android. You can imagine you're looking out the window of a Federation starship as it traverses the quadrant while you navigate your homescreens. As you swipe to a different homescreen panel, the perspective of the starfield changes letting you see a 180 degree arrangement of stars.
The app lets you add a fixed background behind the moving stars, which looks quite nice but can slow down performance quite considerably. You can also customize the number of stars in the field and also the speed at which they fly past the screen. You can also double tap on the screen to get the warp stretching effect as seen on Star Trek: The Next Generation.
Live wallpapers are known for their detriment to your phone's battery life, but I haven't noticed any change in my battery life since having Starfield running. The app is also the best performing live wallpaper I've seen so far. It runs perfectly on my HTC Magic with absolutely no lag, even when swiping homescreens.
Final Verdict
I was a bit sceptical about the live wallpaper idea at first, and the ones that come standard with Android 2.1 didn't do anything to change that. Since installing Starfield however, I've realized how awesome they really are. I will definitely be keeping this as the wallpaper on my phone since it just adds a little extra pizazz to the device. And since it's free, you're almost losing money by not trying it out.
The goods:
- Customizable starfield with optional static background
- Change viewpoint as homescreens pan
- Great performance on lower end phones
Needs improving:
- The only thing I have to criticize is the laggy performance when the background is enabled. In saying that, it probably performs fine on a faster phone such as the Nexus One.
Special Notes: Live wallpapers are only supported on Android 2.1, so you'll need either a Nexus One/Desire or a Droid/Milestone, or you could take a trip over to xda-developers and hook yourself up with a custom ROM.
Note: This review was submitted by James Finnigan as part of our app review contest.


text: I found this site really cool called googlefight.com. From what ive found its pretty popular, but for those who dont know, you type in 2 phrases or words or whatever, it searches the two on google, shows a stick figure fight, and the one with more results wins. Me and my friend have been messing with it for about an hour, and its hilarious for certain things. I propose we find all the funny fights and post the winners, who is with me!? Heres a list of some good ones my dad VS your dad - your dad wins! (psh, barely) red VS blue - red wins! (I lolled hard at that one!) Wii VS PS3 - Wii wins! (as it should) red VS GOD!!! - red wins! (I lolled even harder!) ds VS psp - ds wins! (as it should as well) me VS you - you win! (by a lot sadly) and finally, the fight youve all been waiting for! VS all! all wins, sadly :'( Me and my friend did a bunch of others too, but lets what you guys can find!


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Research involved 370 Chinese primary schoolers.
Increased outdoor activity results in decreased levels of myopia, while near work has no association, according to a recent study. Researchers assessed 370 primary school students in Beijing reinforced previous findings that suggest that the correlation between myopia and outdoor activity is likely due to light exposure as opposed to physical activity.


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Definition: National Lottery
The National Lottery is licensed and regulated by the National Lottery Commission. Some of the proceeds of sale of lottery tickets support 'good causes' which include the arts, heritage, sport, charities and community and voluntary groups as well as projects concerned with health, education and the environment. The proceeds ear marked for heritage are called the Heritage Lottery Fund and are distributed by the National Heritage Memorial Fund.
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Reuters Staff
1 Min Read
Oct 13 (Reuters) - Orient Securities Co Ltd
* Says Sept net profit at 254.3 million yuan ($38.61 million)
Source text in Chinese: bit.ly/2ye1IXD
Further company coverage: ($1 = 6.5857 Chinese yuan renminbi) (Reporting by Hong Kong newsroom)
All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays.
© 2018 Reuters. All Rights Reserved.


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It is Nov. 2, a Friday afternoon, and though practice is over, Charles Tillman is working on his footwork. Nearly all his teammates are off the field and already inside Halas Hall, but Tillman is jogging baby steps in figure eights, right-forward-left-back-right-back-left-forward. He's got to get better. He knows this. This is him getting better.
Thankfully it's Friday, so he's sharp. In his own estimation, he "sucks" in practice early in the week. The coaches trick the defense with play design and new alignments, Tillman explains, and he gets tricked. He misreads routes. He loses.


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Mediocre Fight of the Day: Crying vs Spilled Milk
Oh Dawson, why are you always crying? There there, it's just a little milk. We have plenty more in the refrigerator. Oh, I forgot to go to the store… well I can get some more for you. Hush now, things will be all right. We have some orange juice. Shhh, slow down, I can't understand you. You're blubbering like a little girl. What? You're not upset about the milk? Then why the hell are you being such a little bitch.
Ohhh, you just watched that Sarah Mclachlan commercial with a bunch of sad puppies and sad music. I completely understand. You're still kind of a pansy though.
As always, if you have a mediocre fight you'd like to see contact us any way your little heart desires. Leave a comment here, tweet us @MediocreFight, find us on Facebook, shoot us an e-mail at The Mediocre Fight, or spell it out in my bowl of alphabet soup. Mmmm, soup.


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Legal Status
Proposed Rule
Document Details
Published Document
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) orally administered drug products for relief of symptoms associated with overindulgence in food and drink to include an additional use for products that contain bismuth subsalicylate as an active ingredient labeled for the relief of symptoms of upset stomach due to overindulgence resulting from food and drink. This proposal is part of FDA's ongoing review of OTC drug products.
Submit written or electronic comments by April 5, 2005. Please see section X of this document for the proposed effective date of any final rule that may publish based on this proposal.
You may submit comments, identified by Docket No. 1982N-0166 or RIN 0910-AF51, by any of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
- Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site.
- E-mail: firstname.lastname@example.com. Include Docket No. 1982N-0166 or RIN 0910-AF51 in the subject line of your e-mail message.
- Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and Docket No. or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://www.fda.gov/dockets/ecomments, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the "Request for Comments" heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/dockets/ecomments and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.Start Further Info
Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2307.End Further Info End Preamble Start Supplemental Information
I. Background
In the Federal Register of October 1, 1982 (47 FR 43540), FDA published an advance notice of proposed rulemaking to establish a monograph for OTC orally administered drug products for relief of symptoms associated with overindulgence in alcohol and food, together with the recommendations of the Advisory Review Panel on OTC Miscellaneous Internal Drug Products (the Panel), which was the advisory review panel responsible for evaluating data on the active ingredients in these drug products (§ 330.10(a)(6) (21 CFR 330.10(a)(6))).
In the Federal Register of December 24, 1991 (56 FR 66742), FDA published the proposed rule (in the form of a TFM) for OTC orally administered drug products for relief of symptoms associated with overindulgence in food and drink. In the Federal Register of May 5, 1993 (58 FR 26886), FDA proposed to amend the overindulgence TFM to include a Reye's syndrome warning for OTC drug products containing bismuth subsalicylate. In the Start Printed Page 742 Federal Register of April 17, 2003 (68 FR 18861), FDA published a final rule to revise the Reye's syndrome warning (§ 201.314(h) (21 CFR 201.314(h))) to include OTC drug products containing nonaspirin salicylates (e.g., bismuth subsalicylate) as active ingredients. FDA stated that there was no need to address this warning in a separate rule for overindulgence drug products containing bismuth subsalicylate (68 FR 18861 at 18862). Thus, the April 17, 2003, final rule completed the May 5, 1993, proposed rule. Products containing bismuth subsalicylate as an active ingredient must contain the required Reye's syndrome warning statement as of April 19, 2004, except that products with annual sales less than $25,000 have until April 18, 2005, to be in compliance.
In the Federal Register of March 17, 1999 (64 FR 13254), FDA established a standardized format and content for the labeling of all OTC drug products (see § 201.66). The labeling in the TFM and the labeling in this amendment are not in that format. However, the labeling in the final monograph (FM) will incorporate the standardized labeling format and content. In response to the TFM, FDA received a number of comments and is addressing part of one comment in this document. The remaining comments will be addressed in the final rule. All "OTC Volumes" cited throughout this document refer to information on public display in the Division of Dockets Management (see ADDRESSES).
II. The Comment's Recommendation, Arguments, and Data
One comment recommended that FDA include combination upset stomach/antiflatulent (antigas) drug products containing bismuth subsalicylate and simethicone in the overindulgence monograph for the relief of upset stomach and gas due to overindulgence in food and drink. The comment provided the following arguments and data to support its recommendation.
- FDA's "General Guidelines for OTC Drug Combination Products, September 1978" (Ref. 1) provide that Category I active ingredients from different therapeutic categories may be combined to treat different symptoms concurrently if each ingredient is present within its established safe and effective dosage range, and the combination meets the OTC drug combination policy in all other respects. FDA's OTC drug combination regulations (§ 330.10(a)(4)(iv)) provide that an OTC drug may combine two or more safe and effective active ingredients and may be generally recognized as safe and effective when each active ingredient makes a contribution to the claimed effect(s); when combining of the active ingredients does not decrease the safety or effectiveness of any of the individual active ingredients; and when the combination, when used under adequate directions for use and warnings against unsafe use, provides rational concurrent therapy for a significant proportion of the target population. A combination drug product containing bismuth subsalicylate and simethicone would combine two Category I active ingredients as specified in these Guidelines and meet the requirements of this regulation.
- FDA proposed bismuth subsalicylate as safe and effective for the relief of symptoms of upset stomach associated with overindulgence in food and drink in the TFM, and simethicone is included in the antiflatulent monograph (21 CFR part 332). Bismuth subsalicylate acts in the stomach to relieve upset stomach/indigestion symptoms such as nausea, heartburn, and fullness, while simethicone acts in the stomach to break up gas bubbles resulting from overindulgence in food and drink. Together, these active ingredients will provide relief from upset stomach symptoms occurring in the presence of gas.
- Combining the active ingredients does not decrease the safety and effectiveness of either ingredient. The comment cited data to support that (1) Bismuth subsalicylate does not decrease the foam-reducing capacity of simethicone (Ref. 2), (2) serum salicylate bioavailability of a combination of bismuth subsalicylate-simethicone was equivalent to bismuth subsalicylate alone in dogs (Ref. 3), and (3) the combination and bismuth subsalicylate alone in rats provided equivalent stomach protection against alcohol (Ref. 4).
- The combination provides rational concurrent therapy for a significant proportion of the target population. The comment noted a consumer study of 285 subjects suffering from upset stomach due to overindulgence in which 56 percent of the subjects reported gas as one of their symptoms (Ref. 5). The comment mentioned another consumer study of 159 adults who reported having gas concurrently with symptoms for which bismuth subsalicylate has been shown to be effective (Ref. 6). The percent of adults reporting gas with each symptom included: Fullness/bloating (57), upset stomach (55), indigestion (44), and heartburn (24).
- Antacid-simethicone combination products were included in the antacid monograph (21 CFR part 331) and the antiflatulent monograph without any supporting clinical data. FDA's determination to allow this combination was based on a reasonable expectation that simethicone will be effective if used in combination with an antacid drug product (38 FR 31260 at 31266, November 12, 1973). Further, FDA has proposed that any antacid covered by the antacid monograph may be labeled "for the relief of * * * upset stomach associated with * * * overindulgence in food and drink" (56 FR 66754 at 66756, December 24, 1991). FDA did not review any clinical data to support the indication of upset stomach and gas due to overindulgence in food and drink.
III. FDA's Evaluation of the Comment's Recommendation
FDA has evaluated the comment's recommendation and reconsidered the Panel's review of bismuth subsalicylate for the relief of symptoms of upset stomach associated with overindulgence in food and drink. The Panel stated that upset stomach that occurs as a result of overindulgence in food and drink consists of a group of symptoms that includes heartburn, fullness, and nausea (47 FR 43540 at 43543 and 43545). One of the indications statements that the Panel recommended for products containing bismuth subsalicylate included these symptoms: "For the relief of upset stomach associated with" (select one or more of the following: "nausea," "heartburn," and "fullness") "due to overindulgence in the combination of food and drink." (See 47 FR 43540 at 43550 and 43558.) FDA proposed this indication statement without the words "the combination of" in § 357.950(b)(2) of the TFM (see 56 FR 66742 at 66751).
The Panel discussed the consumer study of 285 subjects (Ref. 5) (47 FR 43540 at 43545), cited by the comment, and noted that 96 percent of the subjects had at least one of the symptoms of "gas (fullness), heartburn (or acid indigestion), or nausea" and that 56 percent [the highest percentage] reported gas as one of their symptoms. The Panel cited studies by Newsom (Ref. 7) and by Berkowitz (Ref. 8) (47 FR 43540 at 43548 to 43549) to support the effectiveness of bismuth subsalicylate for treating upset stomach due to overindulgence. The Newsom study was subsequently published in the Archives of Internal Medicine (Ref. 9).
Newsom conducted a randomized, placebo-controlled, double-blind, multiple-crossover study (Refs. 7 and 9) to evaluate the effectiveness of bismuth Start Printed Page 743subsalicylate to relieve symptoms in subjects with a history of episodic, acute (having a short and relatively severe course) indigestion. The study involved 48 adult subjects 18 to 49 years old (20 men, 28 women). Two additional subjects began the study but were later excluded by the investigator because of abnormal laboratory values. The study medication consisted of either 16.7 milligrams per milliliter (mg/mL) of bismuth subsalicylate suspended in the vehicle or a placebo of vehicle only. The two preparations were similar in appearance, flavor, and viscosity. Each subject received three bottles of each formulation with a computer-generated random sequence of use for treating six episodes over a 7-month period. The subjects were instructed to take the study medication only when they experienced two or more of the symptoms and to take 30 mL every 30 minutes as needed for a total of eight doses (up to 240 minutes). Subjects recorded specific symptoms and the time they first occurred, rating symptom severity on a 10-point scale 15 and 30 minutes after each dose. Subjects reported the time when relief occurred. After six episodes, each subject evaluated each preparation three times.
Newsom defined indigestion or acute gastrointestinal discomfort as a symptom complex consisting of two or more of the following symptoms occurring during or after ingestion of food: Nausea, heartburn, upper-abdominal pain, flatulence (gas) and eructation (belching), sense of fullness, or a feeling of abdominal distention. Stedman's Medical Dictionary (Ref. 10) defines indigestion as a nonspecific term for a variety of symptoms resulting from a failure of proper digestion and absorption of food in the alimentary tract [relating to the organs of digestion]. FDA notes that the investigator's definition of indigestion or acute gastrointestinal discomfort is consistent with the Stedman's definition in that the dictionary's term is nonspecific and the investigator's symptoms relate to the digestive system.
The 48 test subjects had no significant differences in reported symptoms or identified causes in the six individual episodes of symptoms. Eating specific foods was the most commonly identified cause of symptoms, followed by overeating. The overall relief of symptoms showed more episodes treated with bismuth subsalicylate were relieved (132/144) than were episodes treated with placebo (121/144). However, the difference between the two groups was not statistically significant (0.05<p<0.10). However, when time to relief was evaluated in 30-minute intervals, the episodes treated with bismuth subsalicylate were relieved in 90 minutes (median) compared to 120 minutes (median) for episodes treated with placebo. The difference was statistically significant (p<0.01). In addition, the differences in time to relief were significant at the time intervals of 31 to 60, 61 to 90, and 91 to 120 minutes (p<0.01). Beginning at 30 to 45 minutes post-medication, a statistically significant more rapid decrease in severity of nausea, heartburn, flatulence and eructation, and sense of fullness occurred in the subjects receiving bismuth subsalicylate compared to subjects receiving placebo. The feeling of abdominal distension was less severe at 90 minutes with bismuth subsalicylate, but the severity of upper abdominal pain was no different with either treatment. Comparing the time to relief shows that bismuth subsalicylate provided significantly faster relief than placebo for nausea, heartburn, flatulence and eructation, and sense of fullness. FDA concludes that this study supports that bismuth subsalicylate relieves the symptoms of flatulence and eructation, which are symptoms from gas. The study also supports that bismuth subsalicylate relieves the sense of fullness, which might be related to gas.
Berkowitz conducted a randomized, placebo-controlled, double-blind study (Ref. 8) to evaluate the effectiveness of bismuth subsalicylate to relieve gastrointestinal symptoms, commonly termed as "upset stomach," from consumption of food and drink. One hundred thirty two healthy adult subjects fasted for 6 hours and then were provided unlimited quantities of provocative food and drink. The subjects were provided a diary to record eight symptoms, degree of discomfort (none, mild, moderate, severe), and the time of occurrence. The symptoms were:
- stomach queasiness/nausea
- heartburn
- sense of fullness/bloated feeling
- belching
- bitter or acid taste in mouth
- passing gas/wind
- stomach pain/cramps
- other symptoms
The subjects were instructed to take 30 mL of the test medication when symptoms first occurred and to repeat the dose every 30 to 60 minutes, if needed, up to eight doses. The test medication (bismuth subsalicylate) and the placebo were prepared as white, opaque suspensions identical in flavor and viscosity. However, Berkowitz did not mention the concentration of the bismuth subsalicylate preparation. Subjects recorded the time the dose was taken and the degree of relief obtained (none, poor, good, excellent).
Ninety-one of the 132 subjects developed symptoms that required medication, with 43 taking bismuth subsalicylate and 48 taking placebo. Comparison of the two groups showed no significant demographic or baseline differences. The number of subjects and the percent of 91 total subjects reporting the symptoms were as follows:
- stomach queasiness/nausea - 50 (55%)
- heartburn - 48 (53%)
- sense of fullness/bloated feeling - 66 (73%)
- belching - 50 (55%)
- bitter or acid taste in mouth - 18 (20%)
- passing gas/wind - 30 (33%)
- stomach pain/cramps - 17 (19%)
The number of symptoms reported is greater than the number of subjects because subjects reported more than one symptom. Berkowitz performed a statistical analysis of the four relief categories for each symptom and for overall relief. Berkowitz found that bismuth subsalicylate was significantly more effective than placebo for each category except bitter/acid taste. When the analysis was done using (1) Two relief categories (none and poor counted as failure, and good and excellent counted as success) and (2) time to good or excellent relief for each symptom, Berkowitz found that bismuth subsalicylate was significantly more effective and provided significantly faster relief than placebo for relief of nausea, fullness, heartburn, belching, and overall relief. There was no statistical difference in relief of stomach pain/cramps, passing gas, and bitter/acid taste. FDA finds that, although all data are not clearly shown in this study, the results support that bismuth subsalicylate is effective in relieving nausea, heartburn, fullness, and belching. FDA notes that the medical definitions of flatulence, eructation, and bloating are defined using the word gas. While "fullness" is not defined in Stedman's Medical Dictionary (Ref. 10) or in Dorland's Illustrated Medical Dictionary (Ref. 11), Berkowitz combined the term "fullness" with the term "bloating," which refers to abdominal distention from swallowing air or from intestinal gas, and showed that bismuth subsalicylate relieved fullness and bloating.
FDA notes that, in evaluating the consumer study of 285 subjects (Ref. 5) (47 FR 43540 at 43545), the Panel noted that 96 percent of the subjects had at least one of the symptoms of gas (fullness), heartburn (or acid indigestion), or nausea, and that 56 Start Printed Page 744percent [the highest percentage] reported gas as one of their symptoms. Nonetheless, the Panel used the term "fullness" (and not "gas") in its proposed indication for overindulgence drug products containing bismuth subsalicylate (47 FR 43540 at 43558). FDA believes that the Panel also found that bismuth subsalicylate relieves gas due to overindulgence in food and drink, but chose to use the word "fullness" instead in its recommended indications statement. FDA also points out that its current indications statement for OTC antiflatulent drug products containing simethicone in § 332.30(b)(2) states: "(Select one of the following: 'Alleviates' or 'Relieves') (select one or more of the following: 'bloating,' 'pressure,' 'fullness,' or 'stuffed feeling') 'commonly referred to as gas'." Thus, FDA already acknowledges that the term "fullness" encompasses the term "gas."
As the comment noted, the combination of bismuth subsalicylate and simethicone is subject to FDA's combination drug policy (see section II of this document). However, FDA notes that a bismuth subsalicylate-simethicone combination is different than the antacid-simethicone combination that the comment discussed. Simethicone is a monograph ingredient (see § 332.10) for antiflatulent use (to relieve fullness and bloating commonly referred to as gas). Bismuth subsalicylate is not included in the antacid monograph but based on the information and analysis in this document has an antigas (antiflatulent) effect when relieving symptoms of overindulgence in food and drink. This analysis and finding are new information that the comment did not have when it proposed a bismuth subsalicylate-simethicone combination product.
FDA's regulation in § 330.10(a)(4) sets forth the standard for determining whether a combination drug product may be generally recognized as safe and effective and not misbranded. Section 330.10(a)(4)(iv) states that "an OTC drug may combine two or more safe and effective active ingredients and may be generally recognized as safe and effective when each active ingredient makes a contribution to the claimed effect(s) * * *." FDA's "General Guidelines for OTC Drug Combination Products, September 1978" ["Combination Product Guidelines"] (Ref. 1) state that Category I active ingredients from the same therapeutic category ["antiflatulent" in this case] that have the same mechanism of action may be combined in selected circumstances to treat the same symptoms if:
- The combination meets the OTC combination policy in all respects;
- the combination offers some advantage over the active ingredients used alone; and
- the combination is, on a benefit-risk basis, equal to or better than each of the active ingredients used alone at its therapeutic dose.
The "Combination Product Guidelines" (Ref. 1) list similar factors in assessing combination drug products with active ingredients from the same therapeutic category that have different mechanisms of action.
FDA does not have any data on the antigas mechanism of action of bismuth subsalicylate to determine if it is the same or different from that of simethicone. FDA also has not received any data to date comparing the antigas effectiveness of a combination of the two ingredients versus either individual ingredient. Further, FDA is not aware of any combination product containing bismuth subsalicylate and simethicone having been marketed. Therefore, FDA needs data from clinical studies showing that the combination of bismuth subsalicylate and simethicone is equal to or better than [offers some advantage over] each of the individual active ingredients used alone at its therapeutic dose for this antigas use. FDA recommends that anyone interested in conducting such studies submit a protocol and meet with the agency before starting the studies. FDA will evaluate the other data (Refs. 2, 3, and 4) that the comment provided to support this combination product when the clinical effectiveness studies are submitted to FDA.
IV. FDA's Proposed Amendment of the Tentative Final Monograph
Based on the Newsom (Refs. 7 and 9) and Berkowitz (Ref. 8) studies, FDA has tentatively determined that bismuth subsalicylate is safe and effective for OTC use for the relief of upset stomach associated with belching and gas due to overindulgence in food and drink. FDA proposes to amend the definition of "upset stomach due to overindulgence in food and drink" proposed in § 357.903 to add the symptoms "belching" and "gas" and to amend the indications statement for bismuth subsalicylate proposed in § 357.950(b)(2) to add "belching" and "gas" as two additional symptoms that manufacturers may select to include in the labeling of these products.
V. Analysis of Impacts
FDA has examined the impacts of this proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year.
FDA believes that this proposed rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. The proposed rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. The Unfunded Mandates Reform Act of 1995 does not require FDA to prepare a statement of costs and benefits for this proposed rule, because the proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.
The purpose of this proposed rule is to expand an indications statement for OTC overindulgence drug products that contain bismuth subsalicylate as their active ingredient. The proposal provides manufacturers the option of including two additional symptoms in their product's indications statement. As this additional labeling is optional, manufacturers may elect to implement it whenever they revise product labeling or may elect not to include the additional information at all. FDA is unable to state exactly how many bismuth subsalicylate products have an overindulgence claim because these products may be marketed with other claims (e.g., for diarrhea) and not have an overindulgence claim. FDA's Drug Listing System (DLS) identifies 334 OTC drug products that contain bismuth subsalicylate and are marketed for use Start Printed Page 745as an antidiarrheal. Some of these products may also have a claim for overindulgence or may want to include a claim for overindulgence. Because these products could be marketed with an overindulgence claim, FDA is counting all such products as potentially affected by this proposed rule. However, because any relabeling resulting from this proposed rule is completely voluntary and can be done when manufacturers are ordering new product labeling, FDA considers any costs resulting from this proposed rule to be negligible. FDA recognizes that frequent labeling redesigns are a recognized cost of doing business in the OTC drug industry. Manufacturers that make voluntary market-driven changes to their labeling can usually do so at a nominal cost. FDA recognizes benefits to both manufacturers and consumers from this proposed labeling change. Manufacturers will have two additional uses for these products to promote to consumers, and consumers will be able to use a single product instead of two products (one for overindulgence and one for gas) to relieve their symptoms resulting from overindulgence in food and drink. FDA did not consider other labeling alternatives.
This analysis shows that FDA has considered the burden to small entities. Therefore, FDA certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required under the Regulatory Flexibility Act (5 U.S.C. 605(b)).
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that the labeling proposed in this document is not subject to review by the Office of Management and Budget because they do not constitute a "collection of information" under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the proposed labeling is a "public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public" (5 CFR 1320.3(c)(2)).
VII. Environmental Impact
FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
VIII. Federalism
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, FDA tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement has not been prepared.
IX. Request for Comments
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
X. Proposed Effective Date
FDA is proposing that any final rule that may be issued based on this proposal be included in the future FM for OTC orally administered drug products for relief of symptoms associated with overindulgence in food and drink and have the same effective date as that FM.
XI. References
The following references are on display in the Division of Dockets Management (see ADDRESSES), under Docket No. 1982N-0166 unless otherwise noted, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA, "General Guidelines for OTC Drug Combination Products, September 1978," Division of Dockets Management, Docket No. 1978D-0322.
2. The Procter & Gamble Co., "In-vitro Foam Reducing Capacity Test: Pepto-Bismol With Simethicone," in C12.
3. Lukacovic, M. F. and K. J. Watters, "Dog Bioavailability Study With Pentagastrin—Pepto-Bismol With Simethicone, PBDB #14," The Procter & Gamble Co., in C12, 1992.
4. Lukacovic, M. F. and K. J. Watters, "Rat Gastric Lesion Study-Pepto-Bismol With Simethicone. EtOH Study—ANTR #53," The Procter & Gamble Co., in C12, 1991.
5. Comment 31-11370, Division of Dockets Management, Docket No. 1978N-0263.
6. "Study #PD 0292-07," The Procter & Gamble Co., in C12.
7. Newsom, J. H., "Evaluation of Bismuth Subsalicylate in Relieving Symptoms of Indigestion," OTC Vol. 170208 (pp. 15-17).
8. Berkowitz, J. M., "Bismuth Subsalicylate in Excessive Alcohol/Food Intake," OTC Vol. 170208 (pp. 11-15).
9. Hailey, F. J. and J. H. Newsom, "Evaluation of Bismuth Subsalicylate in Relieving Symptoms of Indigestion," Archives of Internal Medicine, 144:269-272, 1984.
10. Stedman's Medical Dictionary, 25th ed., Williams & Wilkins, Baltimore, MD, s.v. "indigestion," 1990.
11. Dorland's Illustrated Medical Dictionary, 28th ed., W. B. Saunders Co., Philadelphia, PA, 1994.Start List of Subjects
List of Subjects in 21 CFR Part 357
- Labeling
- Over-the-counter drugs
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 357, as proposed in the Federal Register of December 24, 1991 (56 FR 66742), be amended as follows:End Amendment Part Start Part
PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USEEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 357 continues to read as follows:End Amendment Part
2. Section 357.903 is amended by revising paragraph (a) to read as follows:
(a) Upset stomach due to overindulgence in food and drink. A condition that occurs as a result of overindulgence in food and drink and consists of a group of symptoms that includes heartburn, nausea, fullness, belching, and gas.
3. Section 357.950 is amended by revising paragraph (b)(2) to read as follows:End Amendment Part
(b) * * *
(2) "For the relief of upset stomach associated with" (select one or more of the following: "nausea," "heartburn," "fullness," "belching," and "gas") "due to overindulgence in food and drink."
Dated: December 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-154 Filed 1-4-05; 8:45 am]


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Reliance Jio gets 10,000 mobile numbers to test 4G services
Mukesh Ambani's Reliance Jio Infocomm has been assigned the 10,000 mobile numbers it needs to test its 4G services on a non-chargeable basis, a person familiar with development said.
The Reliance Industries' unit has been given 4,000 numbers in Delhi and Mumbai each and 2,000 in Jamnagar. Telecommunication Engineering Centre (TEC), the technical arm of the department of telecommunications (DoT), has been excluded from the trial records, the person, who did not wish to be named, said.
DoT, however, has guarded the right to publish Reliance Jio's trial findings on its website in case it deems fit to do so in consumer interest, the same person said. RIL did not respond to an emailed query sent by ET seeking information on the development.
ET had reported in December that DoT was mulling allocation of the Mobile Switching Centres (MSC) codes, based on which cellphone numbers are allocated. At the time the TEC had suggested that testing be restricted to a geographic area at a time, and the same infrastructure be used at different circles. It had suggested that the government set a time frame for the test and not allow the company to offer commercial services during this phase.
The DoT had said that since RIL's is the only firm to hold fourth generation airwaves on a national basis, it should be allowed to connect its networks with other telecom companies for testing purposes. Hence the 10,000 people can make and receive calls from existing mobile customers.
Other telecom companies have contested the amendment in regulations that allows Reliance Jio to offer voice services on LTE (long-term evolution), or 4G, technology, which is largely associated with faster mobile internet connectivity. RIL won airwaves and a licence to rollout 4G services in a government-conducted auction in May 2010. The launch of its services, however, has taken more time than vendors and analysts had hoped.
The potential of its offering voice when it launches high-end data services, currently scheduled towards the end of this year, is likely to unsettle competitors, as RIL proposes to shake up the telecom market in the same way as it did about a decade ago when it rolled out low-cost mobile services. The company that is now Reliance Communications was founded by the current promoter and management group of Reliance Jio in 2002-03.
It was widely credited for the sharp decline in mobile call rates and free incoming calls. Reliance Infotel is expected to first roll out 4G services in Delhi and Mumbai. It has been laying fibre optic cable networks in these cities along with a perpetual backbone fibre lease deal with Reliance Communications worth 1,200 crore. RIL has also entered into contracts with Ericcson, Samsung, IBM, and Microsoft for building networks, providing security solutions and for IT integration.


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text: Magpie Small 256×320 Medium 511×640 Large 818×1024 Download Tiff Original 1918×2400 | (2.9 MB) Description The magpie builds its nest in a high tree or a lofty hedge. It is omnivorous, but prefers meat, such as small game. Keywords avian, bird, Magpie, passeres, stream Galleries Birds: M-O Source: S. G. Goodrich Animal Kingdom Illustrated Vol 2 (New York, NY: Derby & Jackson, 1859)


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Peter Gillies brings a rich history of private sector and academic experience to his role as Founding Director of the New Jersey Institute for Food, Nutrition, and Health. He earned a B.Sc. (Summa cum Laude) in biochemistry and a PhD in medical science from McMaster University in Canada. After several years of postdoctoral research at the Chemical Industry Institute for Toxicology in Research Triangle Park, NC, he joined DuPont's Central Research & Development division where he was a basic researcher in the company's life science enterprise. While at DuPont, Peter held numerous leadership roles including Director of Cardiovascular Disease Research for atherosclerosis and hyperlipidemia drug discovery and DuPont Fellow for the company's emerging Nutrition and Health business platform. He also held adjunct professorships at the University of Delaware, the University of Toronto, and Pennsylvania State University where he supervised PhD students and postdoctoral researchers. Peter is an elected Fellow of the American Heart Association, an elected member of the Society of Toxicology, member of the National Lipid Association and the American Society of Nutrition. In recent years, Peter's attention has turned to the intersection of nutritional genomics and ethics, and the educational needs of students and empowered consumer/patients in an increasingly molecular world. Some examples of Peter's scholarship are listed below:
- Gillies, P.J. and Vanden Heuvel, J.P. (2013) Nutrigenomic Approaches to Unraveling the Physiological Effects of Complex Foods, Chapter 4. In "Nutrigenetics and Nutrigenomics in Functional Foods and Personalized Nutrition", Taylor and Francis, Lynne Ferguson (Editor)
- Gillies, P.J. and Schaefer, E.J. (2013) Clinical benefits of eicosapentaenoic acid in humans. United States Patent Application No. CL4938-US-CNT[1] filed May 24, 2013
- Gillies, P.J., Bhatia, S.K., Belcher, L. A., Hannon, D.B., Thompson, J.T., and Vanden Heuvel, J.P. (2012). Regulation of inflammatory and lipid metabolism genes by eicosapentaenoic acid-rich oil. Journal of Lipid Research 53:1679-1689.
- Roussell M.A., Hill A.M., Gaugler T.L., West, S.G., Vanden Heuvel , J.P., Alaupovic, P., Gillies, P.J., and Kris-Etherton, P.M. (2012). Beef in an optimal lean diet study: effects on lipids, lipoproteins, and apolipoproteins. American Journal of Clinical Nutrition 95:9-16.
- Gillies, P.J., Harris, W.S., and Kris-Etherton, P.M. (2011). Omega-3 fatty acids in food and pharma: The enabling role of biotechnology. Current Atherosclerosis Reports 6:467-473.
Peter sees the challenges and responsibilities of building the New Jersey Institute for Food, Nutrition, and Health as the capstone opportunity of his scientific career; an opportunity to give back to the next generation of scientists...scientists who will pursue careers in an increasingly interdisciplinary world where collective success and community responsibility are core values.
Peter J. Gillies, Ph.D.
Phone: 848-932-3500
Email: firstname.lastname@example.com
Current CV (PDF)


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Reduced Reporting Requirements!Click here for details.
This toolkit contains valuable information to assist State agencies with the management and compliance of their MBE and SBR programs. A working knowledge of Excel is required to prepare the MBE and SBR reports. If you are not familiar with this software application, click here to access Microsoft training resources or visitThe HUB, Maryland's Learning ManagementSystem (LMS), to access a catalog of training classes available to State employees.
Instructions for submitting the FY2019 MBE Strategic Plan was provided to all MBE Liaisons by email on May 16, 2018. Please refer to these detailed instructions when completing your plan. Forward your submission to firstname.lastname@example.com and label it "FY2019 MBE Strategic Plan."
The FY2019 MBE Strategic Plan is due Tuesday,July 31, 2018 by COB.
If you have questions about the FY2019 Strategic Plan, please submit them in writing to Lisa Sanford at firstname.lastname@example.com.
The FY2019 Procurement Forecast must be completed and submitted on or before Saturday, June 30, 2018. Detailed instructions and a template for submitting the reports are provided below.
Quarterly reports are due no later than 30 days following the quarter/month being reported and contain data since the start of the fiscal year July 1, 2018.Email in EXCEL FORMAT to firstname.lastname@example.com.
To assist agencies using Statewide FMIS, the following link allows certain FMIS standard reports to be downloaded electronically. You must contact the Department of Information Technology's (DoIT) Service Desk to obtain a user name and password.
The following forms are provided to use with procurement solicitations that contain MBE subcontracting goals. Please note that the forms have been revised due to MBE Program changes that became effective October 1, 2017.
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Alanya Castle
|Alanya Castle
|Alanya Kalesi
Walls and landward fortress of Alanya Kale
|General information
|Architectural style
|Seljuk architecture
|Alanya, Turkey
Alanya Castle (Alanya Kalesi) is a medieval castle in the southern Turkish city of Alanya.
Most of the castle was built in the 13th century under the Seljuq Sultanate of Rûm following the city's conquest in 1220 by Alaeddin Keykubad I, as part of a building campaign that included the Kızıl Kule.
The castle was built on the remnants of earlier Byzantine era and Roman era fortifications. After the area was pacified under the Ottoman Empire, the castle ceased to be purely defensive, and numerous villas were built inside the walls during the 19th century. Today the building is an open-air museum. Access to the seaward castle is ticketed, but much of the area inside the wall, including the landward castle is open to the general public.
The castle is located 250 metres (820 ft) high on a rocky peninsula jutting into the Mediterranean Sea, which protects it from three sides. The wall which surrounds the castle is 6.5 kilometres (4.0 mi) long and includes 140 towers. 400 different cisterns were built to serve the castle.[1] In 2009, city officials filed to include Alanya Castle and Tersane as UNESCO World Heritage Sites, and were named to the 2009 Tentative List.[2][3]
- ^ "The Citadel of Alanya". Alanya Municipal Government. 2002. Archived from the original on 22 July 2011. Retrieved June 16, 2011.
- ^ "Alanya in line for 'World Heritage' tag". Hürriyet. February 4, 2009. Retrieved February 5, 2009.
- ^ "5 more sites from Turkey on UNESCO's World Heritage Tentative List". Today's Zaman. April 24, 2009. Archived from the original on 26 April 2009. Retrieved April 24, 2009.
External links[edit]
|Wikimedia Commons has media related to Alanya Castle.
Coordinates: 36°32′00″N 31°59′27″E / 36.53321°N 31.99076°E
- Buildings and structures completed in 1226
- 13th-century fortifications
- Seljuk architecture
- Alanya
- Castles in Turkey
- Buildings and structures in Antalya Province
- Tourist attractions in Antalya Province
- Forts in Turkey
- Museums in Turkey
- Buildings and structures of the Sultanate of Rum
- Castles in Antalya Province