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Make Energy, Not Excuses
By Kevin Kernan
Enough with making excuses. How about making energy?
How about one of these excuse-making MLB managers say what's really wrong with his team and start calling players out for poor play.
Before this 60-game season started I said teams that play with energy and play fundamentally sound baseball will be the teams that have success.
Tweets by Kevin Kernan
This season has opened a Pandora's Box of what is wrong with MLB, and enabling managers have made some of the weakest excuses I have ever heard.
The most exciting teams are teams that play with a blast of energy.
Those teams are the Padres, Rays, A's, White Sox and to a lesser degree Blue Jays and Marlins.
Other teams meeting expectations include the Twins, Cubs and Indians.
All those teams are making the most of the situation and have overcome speed bumps along the way.
Early on this season I noticed when I watched Padres games without real fans and only fake fan noise, you could hear the Padres dugout explode with excitement over a hit or even a walk.
The players were into the game, each pitch. You could feel the energy and there would be a roar on a base hit.
The sound of defeat is a player or manager making an excuse or just mouthing analytical gibberish.
That's the sound of victory these days. The roar of the dugout crowd.Right now the Yankees lead the world in that department, led by Aaron Boone, who is constantly covering for his underachieving players like catcher Gary Sanchez, saying things like "behind the scenes he's working his tail off.''
The worst excuse was when backup catcher Kyle Higashioka said it was difficult for Yankees pitchers to read the catcher's signs at Sahlen Field as the Buffalo Blue Jays torched Adam Ottavino and the bullpen for a 10-run inning.
The catcher was trying to protect his pitchers but let's at least deal in reality, please.
" We played hard."
BUFFALO, NEW YORK - SEPTEMBER 07: Adam Ottavino #0 of the New York Yankees reacts after giving up six runs, including a grand slam to Danny Jansen #9 of the Toronto Blue Jays, during the sixth inning at Sahlen Field on September 07, 2020 in Buffalo, New York. The Blue Jays are the home team and are playing their home games in Buffalo due to the Canadian government's policy on coronavirus (COVID-19). (Photo by Bryan M. Bennett/Getty Images)
Sure, the bright lights of Buffalo don't compare to the bright lights of New York City, deal with it.
Don't make bizarre excuses.
Ottavino had complained that the Buffalo Blue Jays might have been stealing signs because evidently the Yankees needed to simplify their signs – because the pitcher couldn't see the intricate set of signs.
Buffalo is a minor league ballpark that was refurbished to major league standards, including lights. So that is that.
Evidently the lights were good enough for BBJ batters to track Ottavino's pitches and bash them even without their two top hitters Bo Bichette (.361 average) and Teoscar Hernandez (14 home runs, .995 OPS) out with injuries.
Loss after loss, managers continue to roll out the excuse: "We played hard."
Do you want a cupcake and a gold star, too for your players?
Sep 6, 2020, FOX Sports Ohio, David Bell reflects on Reds late game loss
This PT Generation – PT stands for Participation Trophy – is evidently so soft managers can't even begin to hint at the truth for fear their fragile players will turn to stone.
By making such weak excuses for sign stealing, the Yankees make their legitimate argument about the electronic sign stealing Astros, weaker.
That is the excuse culture the Yankees have created.
After covering sports for 45 years this is my rule of thumb: Bad teams make bad excuses. Good teams find a way to suck it up.
It is really that simple.
Another MLB third generation manager – like Boone – that is making excuses is Cincinnati's David Bell, a nice guy who appears to be caught in Analytics Hell with that Reds front office.
Are these managers so short of confidence, so desperate to keep their puppet jobs that they have to sell out on a daily basis? Bell does not hold his players accountable for their constant screw-ups.
After his team of underachievers dropped to 18-24 and was shutout by the Cubs – remember the Reds were picked by many to have a breakout season – Bell said this, all with a straight face, "We continue to play, we continue to compete. This team cares tremendously about going out and doing everything they can to win. That's all we can do.''
That's all we can do?
Are you kidding me? Do you watch your team play and all the fundamental mistakes? The ghastly bullpen?
Have you witnessed any of that? That's all we can do?
BALTIMORE, MD - SEPTEMBER 02: Jake Marisnick #16 of the New York Mets crashes into the wall trying to catch a triple hit by Pedro Severino #28 (not pictured) of the Baltimore Orioles in the second inning at Oriole Park at Camden Yards on September 2, 2020 in Baltimore, Maryland. (Photo by Greg Fiume/Getty Images)
The Reds, Yankees and of course the Mets, it is always the Mets, are three of the most underachieving teams in the majors.
The Mets and Yankees have new pitching coaches this season, bringing in younger coaches with little experience, but they do have high-speed cameras that are going to make them pitching coaching gurus and propel the pitchers to new heights of success.
All by watching video and getting that spin rate off the charts.
Meanwhile, former Yankees pitching coach Larry Rothschild, just your lifelong baseball hard worker who kept that staff together, is in San Diego living the good life with the high-flying Padres.
Rothschild does not suffer fools and makes his pitchers work. It's not just about looking at video and giving the pitcher a pat on the backside.
There is some old school tough love in his style of coaching. It is amazing that he is even allowed to have such a style these days.
Give me accountability over analytics any day of the week.
SAN DIEGO, CA - AUGUST 20: Austin Hedges #18, Dinelson Lamet #29 and Larry Rothschild #38 of the San Diego Padres walk in before the game against the Texas Rangers at Petco Park on August 20, 2020 in San Diego, California. The Padres defeated the Rangers 8-7. (Photo by Rob Leiter/MLB Photos via Getty Images)
Dave Eiland, you'll remember, was jettisoned by the Mets and the player's best friend GM Brodie Van Wagenen in June of 2019 because he was too tough on Mets pitchers. So, how's that working out, Brodie?
Mets starters are 19th in the majors in ERA with a 4.74 mark, hard to do with Jake deGrom leading the rotation, and their relievers are 23rd with a 5.21 ERA – and too many pitchers are getting hurt in Jeremy Heffner's first year as pitching coach with new assistant pitching coach Jeremy Accardo.
Did I mention both men bring a heavy analytical approach to the job?
That's the trifecta of defeat right there. Starters bad, relievers worse and pitchers getting injured.
The Yankees went heavy into analytics with their new pitching coach Matt Blake, who was described as a "progressive pitching coach'' when hired away from the Indians where he was the Tribe's assistant director of player development, overseeing the formation of pitching strategy for the organization.
Brian Cashman went all in on analytics with that move because Rothschild still had a year to go on his contract.
The Yankees are 14th in starters' ERA at 4.50 and 13th with relievers posting a 4.45 ERA.
What scouts are seeing from both the Mets and Yankees are deliveries that are not crisp.
In the Yankees case another major issue is how slow the relievers work. There is no flow. Too busy with intricate signs or checking laminated cards in their caps.
Mechanical flaws are not being cleaned up as quickly as in the past, they tell me.
Arm slots are off a bit, too.
There is more. And this can't be measured by numbers.
Pitching Coach Matt Blake #67 of the New York Yankees poses during Photo Day on Thursday, February 20, 2020 at George M. Steinbrenner Field in Tampa, Florida. (Photo by Mike Carlson/MLB Photos via Getty Images)
First, some telling numbers for the Yankees, wins and losses, the only numbers that count.
The Yankees are 2-7 in fake 7-inning games.
They are 4-6 in one-run games.
On the road they are 7-14.
They are 7-0 against the rebuilding Red Sox.
I said multiple times the Yankees would miss Didi Gregorius and that is evident. He is not the same player he once was, but he is still a clubhouse force, plays with energy and makes the game fun and is doing all that with the Phillies who are hanging in there in the NL East.
It was the wrong move to get rid of Didi and believe young Gleyber Torres, who has the body of a second baseman or third baseman, could excel at shortstop.
Shortstop is like catching, there is so much to the position from a leadership standpoint as well as production. Gleyber has been hurt, too.
Injuries are always the biggest excuse with the Yankees, but they traded for perennially injured Giancarlo Stanton and have not figured out how to keep Aaron Judge on the field.
Watch the Yankees play and you can see they are not having fun.
The only thing that gets them going is home runs, but this year is different. There must be more hitting to the opposite field. This year is a small size analytical year.
You can't just rely on numbers, and this year the game is different in a variety of ways, including no fans in the stands so you have to produce your own momentum and stay on top of that.
In the shorter games you have to create runs.
Do things differently this year.
ARLINGTON, TEXAS - AUGUST 17: Fernando Tatis Jr. #23 of the San Diego Padres celebrates with Eric Hosmer #30 of the San Diego Padres after hitting a grand slam against the Texas Rangers in the top of the eighth inning at Globe Life Field on August 17, 2020 in Arlington, Texas. (Photo by Tom Pennington/Getty Images)
Even the biggest home run of the year, Fernando Tatis' unwritten rules grand slam was a great example of going with the 3-0 pitch with a huge lead.
At the time, Padres manager Jayce Tingler and team leader first baseman Eric Hosmer got on Tatis' case for that hit and he apologized. Tingler labeled it a "learning opportunity'' for Tatis because the Padres were up seven runs in the eighth inning.
Whether you believe in unwritten rules or you think this is all entertainment and anything goes or are somewhere in between, you have to appreciate the Padres talked accountability with Tatis.
That is the bottom line.
They tried to guide him, and his strength of character showed through as he continues to be one of the best and most exciting players in the majors.
That is what sets a tone and that might have lit a bigger fire in Tatis' belly.
The shortstop is a generational star, a natural at the game, and one of the best plays I've witnessed all year is when Tatis was playing in and a blistering line drive nearly took his head off.
He made the catch and smiled just as a Little Leaguer would do when making such a spectacular grab.
Go with the 60-game flow, baby.
Tatis gets it. He plays hard. He's an athlete. He has tools, it's not just about home runs even though the young Padres are called the Slam Diego Padres.
They are keeping the heat on the super-talented Dodgers, who also need to be praised for their ability to live up to expectations in the short season unlike the Yankees.
A short disclaimer: In this bizarre postseason anything is possible especially with the make it up as you go rules that really don't give top seeds much of an advantage. The Yankees and Mets, if they make the postseason, could still both make it interesting because each team has an ace. The Yankees have Gerrit Cole, who has not been the same pitcher as Astros Gerrit Cole, and the Mets have deGrom. Both teams could ride aces to postseason success.
But that is still a long way off and judging off the results of today, both teams are excuse-making disappointments.
In 34 games this season, Yankees catcher Gary Sanchez is batting .121, with a 41% strikeout rate.
For the Yankees, a lot of this dovetails back to Sanchez, who has allowed his natural talent to get away from him, yet Cashman doubled down on Sanchez this year instead of cutting bait.
Sanchez has been in steady decline for years.
But the Yankees arrogantly kept telling people Sanchez was an All-Star.
He was just in a rut.
Manager Joe Girardi of the Philadelphia Phillies
Remember, Joe Girardi saw the Sanchez problems and tried to hold him accountable and that just got him in more hot water with Cashman.
The Yankees also let another key piece walk away to the Tigers in backup catcher Austin Romine, who basically covered for Sanchez' atrocious play. Romine is hitting .253 and is the better defensive catcher. Sanchez is hitting .121.
Girardi has the Phillies sitting in a playoff position.
Since 16 teams make the postseason – yet another sellout by Rob Manfred – another example of lowering the bar. There are fake fans, fake runners awarded second base in extra innings, even if it is only the eighth inning in those dreadful seven-inning doubleheaders and fake playoff chases by teams hovering around .500.
Girardi actually manages Phillies games and has come a long way with a bad bullpen which is not easy to do. He removed Zack Wheeler after 83 pitches the other day against the Mets because he sensed Wheeler was done for that day.
He made a decision.
The Phillies were able to win the game – just barely – but the decision was made and Wheeler didn't like the decision but he respected the decision. Girardi will not allow himself to be a Nerd Puppet and good for him.
Being a manager means making tough decisions, not making excuses.
You have to protect your players, I get it, but you can't make a fool of yourself while doing that.
Accountability is the big thing in baseball and always has been. Players must be held accountable for poor play.
Feelings will get hurt.
Baseball is a game of personalities and performance. That can't be scripted especially in an anything goes 60-game season with no fans.
Make your own energy, not excuses and ride the wave of accountability to success.
Aaron BooneFernando Tatis Jr.Gary SanchezJoe GirardiKyle HigashiokaLarry RothschildMatt BlakeNew York MetsNew York YankeesPadresPhillies
44+ years, columnist at NY Post for the last 23 years prior to joining BallNine. Elected to the NY Baseball Hall of Fame. Former SportsTalk Host (KFMB), ESPN's First Take and Cold Pizza contributor. Frequent guest on radio shows and podcasts nationwide. Author of seven books. Seen in episode 10 of ESPN's "The Last Dance" (the one with Dennis Rodman). First baseball interview he conducted was with Thurman Munson. Now you know why he is America's Most Beloved Sportswriter.
A Bronx Enema
Mr. Perfect Inning, Desi Relaford
Gnat's Ass Accuracy
Rays New World
Ricky Bobby & Polar Bears: Pissing Excellence
Righting a Wrong


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Argentina ST Team
Posted on June 30, 2017 by Second
A team of young adults led by Michael Davis and Philip James will serve with Marcelo Robles and Kyle and Claudia Zimmerman in their work at LaMision Church in Buenos Aires, Argentina. Pray for eyes to see the needs and how they can help in the life and ministry of the church and its existing program. Pray for their work with the Zimmerman's in the shanty town slums. They return July 8.
Steve & Marion
Steve and Marion Spencer are grateful the rainy season brought some relief to the famine in Malawi. Over their twenty plus years there they have witnessed African Bible College bring spiritual relief through training hundreds who are now serving in positions of authority, leadership, and service around the globe. They express gratitude that two of their sons and their wives have been approved to work at ABC Malawi and ask for prayer for safety and health of their family.
For more info on Steve & Marion, see page 72 of the prayer guide.
Austin Smith is quite busy at Belo Horizonte with special events geared to develop relationships and draw students to Christ. Pray for the Spirit to move creatively as Austin considers ways to deepen relationships and conversations and for the staff team to have energy for all these endeavors.
For more info on Austin, see page 64 of the prayer guide.
Paul and Violette Bridgman ask prayer for pastor Katayama to be healed from cancer and return as pastor, though they are grateful to help during his absence. Pray for evangelistic contacts to be made with individuals Paul meets in his volunteer work at the school, and for the salvation of their English class students. Pray church attendees who have not publically professed their faith will do so and be baptized.
Nick and Amanda were grateful to have dinner with the Arab families of the wives in her Bible Study. The medical need of one lady in the Bible Study enabled them to intervene with help which resulted in her restoration to God and the church. Pray for continued opportunities with families and that the conversations can go deeper. Soccer continues to be an outlet for Nick to interact with men resulting in a few home visits as well.
For more info on Nick & Amanda, see page 16 of the prayer guide.
For the third summer in a row Andy and Brooke are sending a team of 15 E. Asian students to work with refugees in the Middle East. They are also in the final phase of training the first team of long-term national teachers to live and work in the Middle East. Starting this summer Andy & Brooke will shift their work to another organization which trains and mobilizes university students in 10 different countries for overseas service. Pray for the summer teams and for Andy and Brooke's transition.
For more info on Andy & Brooke, see page 51 of the prayer guide.
Randy & Martha
Randy recently spoke to international students, some Malay, at a college event in the U.S, that led to more spiritual conversations with attendees. Pray for the team in Malaysia working through a church planting training series with one of the Malaysian churches to have good practicum outings in prayer and outreach in the community. Randy and Martha are grateful for daughter Rachel's accomplishments and that she has been accepted into a new university in the fall.
For more info on Randy & Martha, see page 30 of the prayer guide.
Belize ST Team / Juan Patt
Josh Yates will lead a team of five families to work with Juan Patt and Prince of Peace church to put on a VBS and in the afternoons do some light construction work. Pray for the team as they minister to the little ones, for team unity and physical stamina. Juan hopes to expand his ministry to help a church in another town while they search for a pastor. Pray for his time management and for Maria's recurring problem with migraines.
For more info on Juan & Maria, see page 61 of the prayer guide.
Berlin ST Team
In cooperation with the Kreuzberg Project, Gerry Peak is taking a team to Berlin to gain first-hand knowledge about the refugee crisis and how churches and Christians can get involved. The team will learn about our mission partner "The Refugio" which ministers to refugees and brings hope and shalom to people in crisis and leads people to Christ. Pray for the team and those with whom they come in contact, that God would be glorified through their encounter. They return June 30.
Ukraine ST Team
John and Marilyn Whittemore head to Ukraine for two summer camps – one for orphans and disadvantaged children ages 10-14 and another for older disadvantaged kids and graduates of the orphanages. A team of seven adults and three children from Campus Outreach Thailand will join them again this year. Pray for hearts to be open to learn of Jesus as they play and study together. Pray for safe travel, stamina, and health of the team.

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National Cancer Institute (NCI), (http://www.nci.nih.gov)
Title: NCI Phase II Small Business Innovation Research Renewal Awards for Cancer Diagnosis, Prevention, and Treatment (SBIR [R44])
This is a reissue of PA-04-047, which was previously released on January 5, 2004 and now is divided into separate announcements for SBIR and STTR funding mechanisms. Note that "renewal" awards were formerly called "competing continuation" awards.
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF 424 (R&R) SBIR/STTR Application Guide.
A registration process is necessary before submission and should be started at least two weeks in advance of the planned submission. See Section IV.
1) The application must be submitted to Gants.gov by the submission date (see "Key Dates" below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
93.393, 93.394, 93.395, 93.396, 93.399
Release/Posted Date: November 3, 2005
Opening Date: November 7, 2005
Letter of Intent Receipt Date(s): March 1, July 1, November 1 of each year
Application Submission Dates: Standard dates apply. For details, please see https://grants.nih.gov/grants/funding/submissionschedule.htm#SBIR
AIDS Application Submission Dates(s): See https://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): See https://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): See https://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date: See https://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Expiration Date: December 2, 2005
This funding opportunity announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose additional funding for the competing renewal (formerly "competing continuation") of previously funded Phase II SBIR grants to continue the process of developing products for commercialization that ultimately require approval of a Federal regulatory agency and clinical evaluation up to "proof-of-principle" demonstration, generally only through a Phase II clinical trial. Products for potential development include, but are not limited to: drugs, vaccines, radioligands, biomarkers, medical implants or devices, imaging protocols proposed for clinical use, new software for instrument performance, and diagnostic or predictive assays applicable for cancer diagnosis, prevention, and treatment. Current Phase II SBIR grantees that have developed promising anticancer agents or biologics, new diagnostic or treatment devices, or biological assays for diagnosis or treatment, etc., are welcome to apply.
Because the length of time and cost of drug, device, or assay/biomarker development represent a long-term research and development commitment, a maximum project period of up to 3 years and a budget not to exceed total costs of $750,000 per year (including direct costs, facilities and administrative [F&A]/indirect costs, and fee) will be considered if the time period and amount are well justified. However, for those Phase II applications that include budget requests for expensive studies required for investigational new drug (IND) filing with the Food and Drug Administration (FDA) and/or clinical trials up through only Phase II trials, applicants may request up to $1 million per year total costs if the time periods and amounts are well justified.
The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
No funds have been specifically set aside for this program; the number of awards and the amount of funds provided for awards have not been predetermined.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
This FOA will utilize the Phase II SBIR (R44) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-06-052, which solicits Phase II applications under the Small Business Technology Transfer (STTR [R42]) grant mechanism.
The competing renewal Phase II SBIR application should represent a continuation of support for research and development of the previous work funded by the original Phase II grant;
Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets ALL of the criteria as described in Section III.
Only United States SBCs are eligible to submit SBIR applications. A SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets ALL of the criteria as described in Section III.I.A.
· Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. On an SBIR application, the Project Director/Principal Investigator (PD/PI) must have his/her primary employment (more than 50%) with the SBC at the time of award and for the duration of the project.
Applicant SBCs may submit more than one application, provided each application is scientifically distinct.
Activities supported by a competing renewal of a Phase II SBIR grant may include an extension and expansion of preclinical research and development, clinical testing, and other scientific research and development activities needed to meet the requirements and expectations of Federal regulatory agencies.
A competing renewal Phase II award should not be used to conduct early stage research (e.g., identifying targets for drugs, identification of new and more effective compounds or potential diagnostic markers, initial device/software development, initial assay testing, etc.);
See Section IV.1 for application materials. The application instructions for this FOA are located at the following links:
https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR.doc (MS Word)
https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR.pdf (PDF)
For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites:
A. Submission Review and Anticipated Start Dates
B. Sending an Application to the NIH
The Small Business Innovation Research (SBIR) programs were initiated as a means for government agencies to use small businesses to stimulate technological innovation and to help agencies meet their research and development (R&D) needs. An additional provision of these programs is the expected commercialization of the research.
The small business community has been very active in the innovative development and production of a variety of marketable biomedical research and technology products since the inception of the SBIR programs in 1982. However, the progress made by the SBIR recipient businesses in translating their new discoveries and technologies into clinical benefit for the cancer patient may be hampered by the lengthy process and costs required before commercialization. As a way to alleviate some of these issues, this funding opportunity will provide competing renewal funds for up to 3 additional years to Phase II grantees that have developed promising anticancer agents or biologics, new diagnostic or treatment devices, or biological assays for diagnosis or treatment, and/or other relevant tools. These funds will help businesses to complete the necessary preclinical research and development needed for Investigational New Drug (IND) or Investigational Device Exemption (IDE) filing and other processes needed to meet the requirements and expectations of Federal regulatory agencies prior to clinical evaluation for safety, toxicity, and effectiveness. The products may include, but are not limited to: drugs, vaccines, radioligands, medical implants, imaging protocols proposed for clinical use, instrumentation software, and medical devices.
The competing renewal SBIR Phase II application should represent a continuation of support for research and development of the previous work funded by the original Phase II grant. It is expected that promising results from a previous SBIR Phase I and Phase II grant will indicate the merit and need for further research and development. Clinical investigations and Federal regulatory approvals will ultimately be required before the potential of the product being researched and developed can be translated into the clinic.
Activities supported by a competing renewal of an SBIR Phase II grant may include an extension and expansion of preclinical research and development, clinical testing, and other scientific research and development activities needed to meet the requirements and expectations of Federal regulatory agencies. It is expected that some in vitro or in vivo studies will have been carried out in Phase I or the initial Phase II grants. A competing renewal Phase II award should not, however, be used to conduct early stage research (e.g., identifying targets for drugs, identification of new and more effective compounds or potential diagnostic markers, initial device/software development, or initial assay testing).
Examples of research that would be considered responsive to this program announcement are listed below for illustrative purposes and are not exclusive of other appropriate activities; examples include:
Preclinical studies, including pharmacology and toxicology, and other clinical studies beyond those conducted under the NCI Phase I (R43) and initial NCI Phase II (R44) grants;
Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND), Investigational Device Exemption (IDE), Premarketing Approval (PMA), or Radioactive Drug Research Committee (RDRC) applications;
Assessment of devices, including clinical laboratory assays and/or software, with regard to performance standards related to the FDA approval process, including possible in vivo animal studies and clinical evaluation through Phase II trials only;
Safety and effectiveness studies of novel medical devices and/or software;
Biocompatibility studies of surface materials of putative medical implants;
Evaluation of imaging technologies for screening, diagnostic, or therapeutic purposes;
Evaluation of novel genetic, proteomic, and epigenetic technologies for diagnostic or therapeutic purposes;
Clinical studies up through Phase II trials in normal and patient/disease populations in support of New Drug Application approval by the FDA; and
Clinical studies in normal and patient/disease populations in support of Pre-Market Approval for medical devices, diagnostic assays and/or instrumentation software by the FDA.
This funding opportunity will use the SBIR (R44) grant mechanism. Applications may be submitted for support as Phase II grants as described in the SF424 Research and Related (R&R) SBIR/STTR Application Guide (MS Word or PDF).
A parallel funding opportunity announcement (FOA) of identical scientific scope (PA-06-052) utilizes the STTR (R42) grant mechanism. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the SBIR or STTR Parent FOAs (see Small Business Funding Opportunities web page).
Only Phase II SBIR competing renewal applications of previously funded Phase II SBIR awards will be accepted under this FOA. The previously funded Phase II grant need not have been submitted in response to any particular solicitation, but the application for the competing renewal must propose research and development that represents a logical extension of the previously supported Phase II research as described in this announcement. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
Future unsolicited, competing renewal applications based on this project will compete with all SBIR applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this FOA may be submitted as RESUBMISSION applications through Grants.gov Apply using the standard NIH SBIR submission dates of April 1, August 1, and December 1 (or January 2, May 1, or September 1 for AIDS and AIDS-related SBIR applications).
This funding opportunity uses just-in-time concepts. The modular budget format is no longer accepted for SBIR grant applications. Applicants must complete and submit budget requests using the SF424 (R&R) Budget Component found in the application package attached to this announcement in Grants.gov/Apply.
The SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) indicates the statutory guidelines of funding support and project duration periods for SBIR Phase I and Phase II awards.
Because the length of time and cost of drug, device, or assay/biomarker development represent a long-term research and development commitment, a maximum project period of up to 3 years and a budget not to exceed total costs of $750,000 per year (including direct costs, facilities and administrative [F&A]/indirect, and a fee) will be considered under this funding opportunity if the time periods and amounts are well justified. However, for those Phase II applications that include support for expensive studies required for IND filing with the FDA and/or clinical trials up through only Phase II trials, applicants may request up to $1 million per year total costs if the time periods and amounts are well justified.
Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of the award for both Phase I and Phase II awards, meets all of the following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.103. The term "number of employees" is defined in 13 C.F.R. 121.106.
A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of Size Standards.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.
Title 13 C.F.R. 121.3 also states that control or the power to control exists when "key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise." Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA's size regulations, 13C.F.R. 121.106 – Small Business Size Regulations.
All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.
To maintain eligibility to seek a competing renewal Phase II grant, a Phase II grantee organization should submit an application for the competing renewal Phase II grant within the first six submission dates following the expiration of the initial Phase II award. Other eligibility requirements for a competing renewal Phase II grant are identical to those for the initial Phase II (R44) applications.
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the Project Director/Principal Investigator (PD/PI) must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PD/PI's time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
As defined in 42 C.F.R. 52, the PD/PI is the "single individual designated by the grantee in the grant application … who is responsible for the scientific and technical direction of the project." When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the PD/PI, if at the time of submission of the application, the PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.
If the PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.
This requirement applies also to those individuals engaged currently as the PD/PI on an active SBIR project. All current employment and all other appointments of the PD/PI must be identified in his or her "Biographical Sketch" required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
The NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the HHS SBIR or STTR Parent FOAs (see Small Business Funding Opportunities web page).
To download an Application Package and Instructions for completing the SF424 Research and Related (R&R) forms for this FOA, link to http://www.grants.gov/Apply and follow the directions provided on that site.
A one-time registration is required for institutions at both:
Grants.gov (http://www.grants.gov/GetStarted) and at
Several additional separate actions are required before an applicant SBC can submit an application through Grants.gov. See "Preparing for Electronic Submission" at http://era.nih.gov/ElectronicReceipt/preparing.htm for more details.
Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their business official to determine whether their small business is already registered in both Grants.gov and the Commons.
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide instructions for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA) although some of the "Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
Prepare all SBIR applications using the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) instructions.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this announcement in Grants.gov/ Apply will include all applicable components, required and optional. A completed application in response to this announcement will include the following components.
Research & Related Budget
SBIR/STTR Information
Research & Related Subaward Budget Form
Application Submission Date(s): https://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): https://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date: https://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: https://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: https://grants.nih.gov/grants/funding/submissionschedule.htm
Prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research;
Name, address, and telephone number of the PD/PI;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute/Center (IC) staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed above to the following:
Rosemary S. L. Wong, Ph.D.
Radiotherapy Development Branch
Division of Cancer Treatment and Diagnosis
6130 Executive Boulevard, EPN Room 6015A, MSC 7440
Bethesda, MD 20892-7440 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for express/courier service)
Telephone: 301- 496-9360
Email: rw26f@nih.gov
3.B. Sending an Application to the NIH
Applications in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.
Applications may be submitted to Grants.gov on or after November 7, 2005 (i.e., the Opening Date on Grants.gov) and must be submitted no later than 8:00 p.m. Eastern Time on the application submission date described above (Section IV.3.A.). If an application is not submitted by that date, the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), NIH. Incomplete applications will not be reviewed.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a competing renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a competing renewal award.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) are to be followed, with the following requirements.
Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.
SBIR Phase I applications:
Applications for SBIR Phase I awards may not be submitted under this FOA.
SBIR Phase II applications:
(Reminder: A previously funded Phase II SBIR grant must have been awarded in order to submit under this FOA)
Items 2-5 of the Research Plan component may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
"Introduction" (required for a resubmission application) is limited to three (3) pages.
The Biographical Sketch is limited to a maximum of 4 pages for each senior/key person. (This includes the table at the top of the first page.)
The Phase II application must present a Commercialization Plan (maximum 15 pages) that addresses specific points as described in the Grants.gov SBIR/STTR Application Guide (MS Word or PDF) and the SBIR/STTR Information Component.
There is no further limitation on the total number of pages for the entire Phase II application; however, applicants are encouraged to be succinct.
Part of the Specific Aims (Item 2) of the PHS 398 Research Plan component should include a Gantt chart or equivalent representation of the tasks including the stages at which interaction with the regulatory agencies will occur. In the Preliminary Studies section, there must be a Phase II Final Report that describes the accomplishments of the Phase II efforts that justify this request for competing renewal funds. Those applicants requesting funds for clinical evaluation must follow the instructions applicable for Human Subjects Research as described in the SF424 (R&R) SBIR/STTR Application Guide (see Items 6-10 of the PHS 398 Research Plan and Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.)
Applicants requesting $500,000 or more in direct costs in any year should include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared. If the final data are not amenable to sharing, for example, if they are proprietary, this must be explained in the application. The Small Business Act requires NIH to protect from disclosure and nongovernmental use all SBIR and STTR data developed from work performed under an SBIR and STTR funding agreement for a period of 4 years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR and STTR award, or by agreement between the small business concern and NIH. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center staff likely to accept assignment of their application.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. https://grants.nih.gov/grants/policy/data_sharing and https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.)
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. T The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
Research Consultant and Contractual Costs
The total amount of all consultant costs and contractual costs normally may not exceed 50 percent of the total costs requested for initial Phase II SBIR applications. Competing renewal SBIR Phase II grant applications submitted under this FOA may exceed this guideline when well justified and when those costs are necessary to support required IND/IDE/PMA filing activities, clinical studies or trials, and related expenses not available at the awardee institution. Examples of well-founded reasons for exceeding this guideline include, but are not limited to, subcontracts to clinical research organizations to carry out aspects of clinical evaluation or subcontracts to assure compliance with Good Manufacturing Practices (GMPs).
Commercialization Plan
All Phase II grant applications, including these competing renewal Phase II applications, require a "Commercialization Plan" as described in the SF424 (R&R) SBIR/STTR Application Guide. The Commercialization Plan is meant in part to demonstrate the commercial viability of the product to be researched and developed with SBIR support. Since this competing renewal Phase II application mechanism supports a more advanced stage of research and development activities relative to the original Phase II SBIR (R44) mechanism, the Commercialization Plan should provide a timeline describing more advanced plans and arrangements for commercialization following the completion of the research, as well as Federal regulatory issues to be addressed with the competing renewal funds. Part of a Commercialization Plan could be a clear indication of an arrangement (e.g., strategic alliance, letter of support) with another party through which the final stages of the work might be supported or carried out, including additional clinical trials, FDA submissions, drug manufacturing, and drug commercialization. This example is meant for illustrative purposes; the details of any Commercialization Plan will depend upon the particular circumstances represented in a given application.
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Receive a second level of review by the National Cancer Advisory Board.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR applications. The following will be considered in making funding decisions:
Scientific merit of the proposed project as determined by peer review;
Availability of funds; and
The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Additional Review Criteria
The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.
All SBIR Applications
Significance: Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate?
Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigator: Is the PD/PI appropriately trained and capable of coordinating and managing the proposed SBIR? Are the investigators and well suited to carry out this work? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is the work proposed appropriate to the experience level of the PD/PI and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?
Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Resubmission Applications (formerly "amended") Applications
In addition to the above criteria, the following criteria will be applied to resubmission applications.
1. Are the responses to comments from the previous scientific review group adequate?
2. Are the improvements in the resubmission application appropriate?
Phase II Renewal (formerly "Competing Continuation") Applications
In addition to the above review criteria, the following items will be applied to ALL competing renewal Phase II applications in the determination of scientific merit and the priority score.
1. Does the activity as proposed address issues related to Federal regulatory approval processes?
2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in described in the SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) and the SBIR/STTR Information Component?
3. Does the project carry a high degree of commercial potential as described in the Commercialization Plan?
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
Period of Support: The appropriateness of the requested period of support in relation to the proposed research.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (see https://grants.nih.gov/grants/policy/data_sharing).
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).
Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. It is highly recommended that prospective competing renewal applicants first contact their respective Phase II SBIR Program Director at the various NCI programs to discuss their eligibility and qualification before beginning the process of putting together a competing renewal Phase II SBIR application. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact:
3. Financial or Grants Management Contact:
Grants Administration Branch
6120 Executive Boulevard, EPS Room 243, MSC 7150
Email: williate@mail.nih.gov
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see: http://www.lrp.nih.gov.


Christmas – what does it mean?
I am not a religious person however, I was baptized into the Anglican faith. I attended the Methodist Church Sunday School two houses up from my parents' home in Redcliffe and my children attended Catholic primary and secondary schools. Therefore, I do understand the "real reason" why Christmas is such an important celebration of the Christian faith.
What I find interesting is that as the world becomes more westernized, Christmas is celebrated in many countries where Christianity is not the first religion.
So for these countries, is the "real reason" of the celebration lost or not understood? I sincerely hope not, although the cynic in me sometimes does think that the commercial priority of Christmas has become much more important.
The internet has made the world a very small place and the ability of large multi-national corporations to market to the entire world because of a Christmas celebration is very easy.
The last couple of weeks have again proved to me that Christmas can either be a nightmare for the average person or a shopaholic's dream come true. We are inundated from the second week of November with bundles of Christmas junk mail in our letterboxes and emails from every company who we may have bought something from in the last 12 months promoting their once in a lifetime Christmas sale.
On top of this, we have now Black Friday sales and a new and exciting promotion Cyber Monday – whatever this may be – and this all happens before Christmas and the infamous Boxing Day sale.
The pressure on you to spend money is constant and the stress, depending on your financial and personal circumstances, can be immense.
According to some media outlets, the success of Christmas is measured by how much money has been spent.
I am sure most of you will agree, it does seem to be a rather perverse way of viewing Christmas and the original concept of a Christmas celebration was not based on how much money people could spend.
As I did say right at the beginning of this blog, I am not a religious person. However, I do believe very much in what I understand Christmas to mean.
Christmas is about compassion, tolerance, respect, understanding and a love for your fellow human, regardless of a person's beliefs, colour, lifestyle or choices. Humans are a widely diversified group of individuals who, unlike our fellow animals, possess a genuine ability to be compassionate and understanding – Christmas is a wonderful time for all of us to remember these qualities and to put them into practice if only for one day.
Through my wonderful rose-coloured glasses, I hope Christmas celebrations in countries where Christianity is not the religion of choice are for these reasons and not for the commercial benefits or the advertised perception of the joy we can bring by spending money.
From PK and I, all the very best of the season, have a wonderful time and fingers crossed for a brilliant 2018 – regardless of your beliefs!
Grandchildren – yes, I am that old!


Our global eCommerce client is seeking a UX Designer who can work independently and can think big picture, being able to convert business requirements and user research into an engaging user experience. An important element to this role is being able to balance user and business needs while scoping within the existing technology capabilities that maintains a positive balance between creative integrity and shipping on time.
· Experience working in an Agile or Waterfall environment and should be very well versed in the UX process including discovery, usability, wireframes, visual designs, etc. specifically managing software/digital related projects from a UX perspective, end-to-end lifecycle.
· Stay on task for assigned UX projects for the timely creation, review, approval and delivery of UX deliverables.
· Develop project milestones and collaborate with the Senior Manager to prioritize and define the timeline and project goals.
· Extensive experience wireframing using a prototyping tool such as Axure, Sketch or Omnigraffle.
· Can produce various deliverables such as Content Taxonomy, Site Map, User Flows, Wireframes, and clickable prototypes, etc.
· Able to handle a fast pace work environment.
· Able to work independently, but within a team.
· You are very detailed and organized. Live to ship, but you also have the flexibility to think on you feet, adapt quickly to shifting priorities, and do whatever it takes to get things done.
· You have the ability to build relationships across the organization, both with the immediate design team, and reaching throughout the company with all stakeholders involved.


text:
Changes Give Cycling Catalog Uphill Climb
A change in the design and product focus of its post-holiday mailing this year has Terry Precision Cycling looking to retool for next year.
After mailing 5.25-by-5.25-inch booklets devoted to skorts in January 2001 and 2002, the company switched to a 7-by-10-inch catalog this January that featured a mix of merchandise. Products included jewelry, cycling tights, gloves and helmets — but only two styles of skorts.
The direct marketer of women's cycling-related clothing, gear and accessories expected an average order of $120, the same as last year, but the result has been $90.
"Some of it is the economy," said Jackie Marchand, vice president of sales at Terry Precision Cycling, Macedon, NY. "Another part of it is the design of the book. It's critical that it catches people's attention."
And though the response rate increased about 10 percent from last January's book, it remained below 2 percent.
"I wish we had offered all the skorts in the travel [2003] catalog," said Paula Dyba, vice president of marketing. "We changed so much, so it's hard to say what's going on here. Part of it was the skort phenomenon last year when they bought a skort and a top, kicking the average order up to $120. We gave them that ability this year, but it wasn't as suggestive. There was a little bit of magic about that skort piece last year."
Last year's 24-page booklet was devoted to skorts priced from $55 to $90. A cross-sell promoted moisture-wicking tops from $35 to $60.
"We wanted to do something specific to the skort because we had this popular apparel item that went beyond cycling and could be worn in other sport applications," Dyba said. "Instead of putting it under the cycling umbrella, we tried to attract multisport females. We felt it might be lost in our regular catalogs since a lot of women who play tennis or golf who we wanted to target might not look to a cycling sportswear company for the item."
She said the skort is an unusual garment because of its dual appeal in sport as well as fashion.
"By packaging it with a few tops we could go in a fashion direction as well," she said. "For the square book, the design firm came up with that format as a way of separating the piece from the catalog we produce. The shape of the garment is pretty square, and that size allowed for a lot of focus on the skort itself."
Marchand described the company's target as "athletic women who like to bike [as well as play] golf and tennis. They don't often have children at home and they're affluent, ranging from 25 to 55 years old."
The 2002 skorts booklet mailed to 200,000 recipients. About 75 percent were prospects with names obtained from a dozen lists, including "multisport" lists, magazines and health club participants.
The travel 2003 catalog went to 150,000 recipients, 65 percent of which were prospects.
The company mails about eight catalogs yearly.
"Next January we have some serious things to look at," Dyba said.
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DAY CPM provided comprehensive management on all facets of this expansion project including owner representation and program management. Trios' new Greenfield 74-bed replacement hospital included the development of a 40-acre site and incorporates 160,000 square feet acute care facilities. DAY CPM's involvement covered site development, land use development, permit and plan review, medical equipment and IT technology integration oversight, and overall program management services. Additional master planning support services for future hospital expansion and other outpatient MOB facilities are also under development.
The hospital opened at 7 a.m. on July 14, 2014, with all patients moved by private ambulance from the Auburn Street site by noon.
The new seven-level, 160,000-square-foot facility is connected to Trios Southridge Hospital and provided space for outpatient provider practices, diagnostic imaging, laboratory, physical therapy, cardiac rehab, speech-language services, interventional pain procedures, and a coffee shop with indoor and outdoor seating.


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Pedestrian Killed on I-80 in Iowa City; Victims Identified in Fairfax Train/Car Collision
Bob James Published: September 28, 2021
CBS 2 Iowa's News Now
Two accidents just over 24 hours apart have claimed three lives in eastern Iowa.
Monday afternoon, September 27, at approximately 4:16 p.m., a pedestrian was struck and killed by a vehicle on the eastbound side of Interstate 80 underneath the Highway 1/North Dodge Street overpass. The incident happened near mile marker 246, according to an accident report from the Iowa State Patrol. *The photo above from our news partner, CBS 2 Iowa's News Now, shows emergency responders at the scene.
The Iowa State Patrol is trying to determine the vehicle that struck the pedestrian. An accident report from the Iowa State Patrol asks witnesses or anyone with any information on the incident to call the Iowa State Patrol. They can be reached at (800) 525-5555.
The pedestrian has not been identified, pending notification of relatives.
Sunday afternoon, September 26, at about 4:15 p.m., emergency personnel responded to a vehicle/train accident near Fairfax.
Linn County Sheriff's Office
A media release from the Linn County Sheriff's Office says a vehicle was traveling south from a private railroad crossing when it was hit by an eastbound Union Pacific train. 42-year-old Jason Williams and 44-year-old Amber Wisted, both of Cedar Rapids, were pronounced dead at the scene.
According to KWWL, at least nine people have been killed in the state of Iowa this year in accidents involving trains. Last year, the Federal Railroad Administration reported 757 people died in train incidents. That was the lowest number of fatalities since 2015.
Filed Under: accident, car, fairfax, fatality, nl, pedestrian, train
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Democratic National Convention '96
Pundits reflect on Bill Clinton's acceptance of the presidential nomination, and the news of chief reelection strategist Dick Morris' resignation.
Mandy Grunwald Ed Rollins Walter Isaacson E. R. Shipp Mario Cuomo Garry Wills Dan Rather
'12 Convention Review; '12 DNC; Daley
Tom Brokaw, Jon Meacham, and others on the '12 RNC and DNC. Frmr. White House chief of staff on bin Laden's final day. 52:58
American Politics '96
A conversation about the struggle between Congress and the White House. 19:17
Kurt Russell; Dan Rather; George...
"Escape from Los Angeles." Day two of the '96 DNC; continuing with analysis of the Clintons' showing; Sen. Bradley on the potential of a second term. 54:28
Senator Bill Bradley
Senator Bill Bradley, (D) New Jersey provides analysis on the 1996 Democratic National Convention and the potential of a second term for Clinton. 10:15
CBS News correspondent Dan Rather reports on day two of the 1996 Democratic National Convention. 08:45


For my day job, I run a web design and development company called Lemon Productions as well as a podcast network called SSKTN and whenever I have to do anything with money – invoicing, project estimating, etc. – I use FreshBooks.
It's by far the easiest invoicing system I've tried – and I have tried quite a few.
The fact that it's a web page and online service means that it can automatically send out invoices and reminders for you – without you having to remember to start up a program on your computer and go through your invoices and outstanding payments. It's a huge mental relief to be able to dump reoccurring invoices into FreshBooks and not have to think about them again until one day you get payment notification from a client. Awesomesauce.
Reports and stats coming out the whazoo (that's a technical term) – it's approved by my accountant for tax time. Check out FreshBooks if you're in need of invoicing and project budgeting and want to be able to focus on the actual doing of your stuff instead of invoicing and billing for your stuff.
These recommends pages are for products and services that I actually use myself. I won't recommend something unless I personally am using or have used it. If you decide to use or purchase the service recommended on this page, I will receive a commission which goes towards supporting my writing on this site as well as the podcasting I do at SSKTN. I appreciate your support!


Do you want to get your learner's permit & license? Follow these three steps!
First, begin studying for the written test. City-Line offers written test preparation. Usually, the DMV or your local school will give the test to sophomores.
After you pass your written test and receive a blue card, you can show this card to the DMV to obtain a learner's permit. In New Jersey, state law requires accompaniment by a licensed driving school. After a short vision test, you will receive your learner's permit!
Finally, complete six hours behind the wheel with a licensed instructor. At age 17, you may take your driving test, and we wish you the best of luck! NOTE: Please try to schedule your driving test 3 or more months in advance. Spots fill up VERY quickly.


Are you searching for best messaging app Kik For PC? If your answer is yes then you are in the correct place. Here, we are explaining how to download and install Kik for PC. And you can quickly download this Kik app on your Windows 10,7,8,8.1. Please read this article carefully and get more information about Kik app on computer/laptop. You can easily download the Kik app in any desktop.
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Home Featured Editorials Could Jets' Qvale Surprise on the O-Line?
Could Jets' Qvale Surprise on the O-Line?
Glenn Naughton June 10, 2015
By Glenn Naughton
Is there a dark horse emerging in the battle for the starting right guard position during Jets mini-camp?
One name that has popped up several times during OTA's and again during this week's three-day mini-camp is one that is known to few Jets fans in offensive lineman Brent Qvale (pronounced Kwah-lee).
According to Eric Allen of nyjets.com, Qvale saw significant playing time at right guard during day one of mini-camp after getting a long look at the same spot during the voluntary portion of the team's off-season program earlier this month.
Brent Qvale a 1st-year player from Nebraska, has gotten in a lot of work with 1st unit at RG today.
— Eric Allen (@eallenjets) June 9, 2015
Qvale, a 6′ 6"/315 lb lineman who played both guard and tackle at the University of Nebraska spent last season on the Jets practice squad after getting picked following a tryout with the team. His Nebraska bio reads as follows:
Brent Qvale was a fixture on the Nebraska offensive line for four seasons, and worked with the top unit at tackle during his final two years in the program. Qvale was one of three tackles in the regular rotation for the majority of the season, before stepping into the starting left tackle role for the final five games after widespread injuries hit the line.
The 6-7, 315-pound Qvale suffered an injury of his own against Penn State, but was able to return to start against Iowa on Senior Day. His play helped Nebraska field one of the Big Ten's top rushing offenses again in 2013.
Qvale earned his degree in May of 2013, and played the entire season as a graduate student. He was one of 30 Huskers to earn Academic All-Big Ten honors in 2013, picking up academic all-conference honors for the third straight season.
According to PFF.com, Qvale played 91 snaps last pre-season. In that very limited time, he was graded as an average pass-blocker and a below average run-blocker. Neither statistic is very telling as he was going up against other back ups with limited reps, but in the case of a practice squad player there's rarely going to be extensive information available.
However, we do know that Todd Bowles and the rest of the Jets coaching staff has been plugging him in at right guard, the only unsettled position on the offensive line where there's no shortage of potential starters.
Last year's starter, Willie Colon, is hoping to win his job back while youngsters Oday Aboushi, Dakota Dozier and Jarvis Harrison are among the other candidates working to earn the starting nod.
Hearing that Qvale is getting a significant number of reps given his status as an undrafted free agent versus more experienced players could amount to very little on June 9th, but it with a new regime in place it's worth noting that in a positional battle that could include a half-dozen hopefuls, a notable number of reps are going to Qvale.
With plenty of time between now and training camp there are sure to be several players getting a shot to run with the starters, but recently it's been Qvale which is a good sign for the Jets and their fans as it appears the new staff intends to hold true competitions across the board in 2015. A philosophical departure from the past several seasons in which many youngsters were seemingly overlooked by GM John Idzik and head coach Rex Ryan.
TAGS: brent qvale dakota dozier Jarvis Harrison
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Dogs: There would never be any dogs on the property during use to allow for privacy for the users. Neighbors dogs on two sides are respectful and do not fence fight. My own personal dogs would be out of sight and sound during use. Agility equipment is available to use at owners discretion.
People: Private yard, no humans visible or audible.
1/3 acre fenced with agility equipment available.
Hours of availability: Daytime and early evening hours.
Is the host be present?: I would like to meet guests for the first visit only, just to give an overview of the agility equipment. After that I would not need to interact with guests.
About the Host: I want to give owners of reactive dogs a private place to play without the fear of a dog on dog encounter. I also have agility equipment for those that want to practice somewhere besides their own yard. I have a small dog walk, teeter, tunnel, weave poles and twelve safe soft cup winged jumps.