bronwynrh: (Skeptical)
New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff
Section 207 (FDAMA); Section 513(f)(2) of the FDCA; 21 USC 360c(f)(2)

... yes, this is my work life ...

Anywho, the guidance document helpfully provides a phone number for manufacturers needing specific guidance.

Only the number is for an automated voicemail system. I was directed to enter my 10-digit mailbox number to check my messages.

That was singularly unhelpful.

ETA: Ok, the general number at CDRH led to me to a much more helpful and REAL person. Hooray! Downside is, I forgot to ask one of my questions, so I have to call back. CrapperJohn.
bronwynrh: (24)
In big faded red letters, the sign reads:

To yet another cell-phone obsessed Potentia employee, this means

Did you know that? I didn't know that.

The *wooshwooshwoosh* didn't tip him off, the several throat-clearings didn't tip him off. The sound of bottles being capped and hoses being un-hosed didn't tip him off, either. Nor did the sound of my bag being zipped.

I came around the screen, boob attachments in hand, to find him - no kidding - six inches away from the screen looking at the DO NOT DISTURB sign. I scowled at him and flipped the sign back over the screen, then slammed the door.

Now there's a new sign with bright red lettering:

Last month, the building security guard peeked around the screen. And he knows me and knows what I do back there. I don't know what got into him, but he felt terrible about it. I refuse to acknowledge the building manager, who has peeked back there twice, and who helpfully (and on several occasions) suggested that my sign should read


And there was of course the other Potentia employee who peeked back there when I was still pumping for Samuel. He, too, was on the phone, and was so kind as to give a running commentary as he observed the screen and the sign.

In the spring, I lost a $20 bill in the hallway in front of our laboratory door. I went to the security guard to ask if anyone had turned in the $20 I lost, and explained that I had it in my pocket to buy milkshakes for myself and my then-in-hospital mother. The guard had found it and asked around. One of the Potentia employees had claimed it as his own. The guard was angry that someone had lied to him, confronted the guy, and got my $20 back.

I don't know what's wrong with these people...

In other news, Dixon is a big fan of eating and standing up. See?


I don't mean to neglect Samuel, but the videos I have are still stuck on the camera. He's learning how to say "bicycle" - or, "bi-glglglglglglgle", to hear him tell it. He's picking up all sorts of 4- and even 5-word phrases, like, "Hi Julie, let's play!" and, "Baby Dixon go night night". We have to work hard to understand him, but he's improving. His vocabulary is exploding and his counting and letter-recognition skills are great. I'm just so proud of him and the progress he's making every day.

bronwynrh: (Don't Panic!)
That's all. Just a long, anguished scream.
bronwynrh: (CrazyBoy)
Somebody stop me. Please.

A new grant mechanism came out (thanks again, ARRA 2009), it looks like a great alternative to the mechanism we were pursuing.

I had to go and say so.

The reply: "Great we will do both. I will explain get ready for some hard work."


I can see where we can do both. I can. I just wish I could stop making so much work for myself.
bronwynrh: (Bikini)
Hey! Said I. I said, Hey! There's a whole lotta FDA hoop-jumping we have to do here, before we can do this other thing you want me to do.

So guess who's in charge of mapping out all those hoops? That's right, me.

The search for the government's definition of "medical device" has taken me half an hour of combing through the CFR database. Make that even longer, because the link that was supposed to take me to 21 CFR 201(h) has apparently been erased from the intertubes. Shit... Oh, look! Lazarus link! It's aliiiiiive. Finally!

I've read multiple guidances, and have tried to distill them into something palatable, but it's damn near impossible with some of these things. I'm sorry, you just have to read the whole thing, guys.

9:15 and I want a mojito. And a beach. And my well-tanned man in white shorts, rubbing scented oils into my skin...

*sigh* I'll just take a moment and go to my happy place.

ETA: Ok, so I'm scrolling through the index for 21 CFR (parts 1 to 1499, thankyouverymuch) and come across (332) Antiflatulent products for over-the-counter human use. That's right, the Beano regulation!

Nothing makes you lean libertarian like reading through the CFR. My god.
bronwynrh: (Default)
Mom's blood test showed no abnormal cells. So maybe her low blood counts are simply the result of a slow come-back from the chemotherapy. Doc wants to wait another month before another blood test, and told mom to get lots of rest and don't push herself.


We've been worried that her slow recovery was a recurrence... at least we can set that worry aside for now.

I have photos from Samuel's birthday, but haven't been able to upload them yet. Bad mommy.

He's been picking up a great imitation habit, which is helping immensely with his language. We're not progressing in leaps and bounds, mind you, but we are making progress. He imitates three-syllable phrases - at least the intonations - and occasionally we think we can hear the words. I could swear he said, "I love you" on Saturday. When I read Just For You, he says "bubble!" and "bag broke" (bah bock) - which he picked up all by himself.

He loves to watch golf, and understands that it's good when the ball goes into the hole. We're trying to teach him to shout "in the hooooole!" when the players swing, in hopes that we can station him in the backyard to heckle the golfers there. Right now, he just waves and babbles at them.

Oh, and when you ask him how old he is, he tells you )

Dixon is 6 shots into the 10-shot regimen, and I finally figured out how to do it with the least upset. Thank goodness, he never holds it against me. He's showing some side effects, but I'm not sure that means he's likely to pass the test. I never studied endocrinology to any appreciable degree, but I don't think what we're seeing is any indication that he's going to pass. We certainly haven't seen anything descend, which would be proof positive. Next Tuesday is the last shot, and Wednesday is the blood draw. Then we hurry up and wait for results.

Growing tired of people thinking he's a girl, and realizing that it was making him rather hot at times, and growing tired of cleaning cottage cheese from the tangles, I finally trimmed Dixon's hair. He is no longer MulletBoy, but you can still call him by his other Indian names, ThunderButt and GiggleSnort.

Read more... )

As for work, I got the cancer grant out the door 3 days before the deadline. More hurry up and wait. Thank the gods, the Powers That Be decided that, although another product is a priority, its importance is so great that it would be unwise to write a grant in haste, just to squeeze under the ARRA fund-brella. We'd be doing ourselves a disservice if we tried. So there's one less grant to write OMGRIGHTNOW!

Love that one of my colleagues keeps pointing out that the grant application is cumbersome and obnoxiously, computer-draggingly huge. Yes, yes I know. Glad you're finally getting a taste of what I've been telling you these past three years. Ah, well. I managed to bang this last one out in quick order, with relatively little pain, perhaps indicating that I've finally hit my grantwriting groove.

Er... Yay?

On to IRBs and the whole mess o' bureaucratic forms those entail. Somebody stop me, I'm having too much fun.

Oh hey, I ordered $111 worth of yarn from so I can finish the knitted blanket [ profile] travellight set me on. Thanks, Susan, for the new obsession. I'll try to post a picture of my progress... It's going to be beautiful when I'm finished, sometime around my 43rd birthday.


Apr. 2nd, 2009 03:01 pm
bronwynrh: (Default)
I've been buried in grantwriting Hell for the past week or so, taking work home on the weekend. Now I'm in the deeper level of Hell reserved for grant submission.

Thank you, government, for making the application process even more burdensome on the ol' processor than it was before. I swear, it takes a couple of minutes just to save this Adobe behemoth.

I've not had the energy or time to spare to tell you all about Samuel's birthday celebrations, the epic saga of Dixon's Novarel shots, or the latest - Mom's white counts are still in the toilet.

She just called to tell me her doctor has ordered flow cytometry on her blood to look for... what, I don't know. I can guess, but I don't want to. At any rate, the results will tell him whether or not another bone marrow biopsy is necessary.

The monster, it seems, has not been definitively beaten back, as I had hoped.

I'm scared to pieces, but I can't afford to go to pieces with my work responsibilities hanging over me. I'm on such a short deadline, it's making me sick.

So here's a family portrait. Looking at it makes me happy, and I need happy now.


Mar. 19th, 2009 09:39 pm
bronwynrh: (Don't Panic!)
I knew this next month was going to be pretty awful. The ARRA (spit) included a load of money for the NIH and, in response, the NIH created a brand new grant mechanism, called RC1. They're also setting aside moneys for administrative supplements and competitive revisions (another fancy phrase for "supplement") to existing projects.

As soon as the ARRA was signed, I knew there would be a flurry of ZOMG WE GOTTA APPLY FOR THIS NOW! BRONWYN!!!!

Sure enough...

"I've got like 5 grants we need to write!"
"We've gotta get a supplement for our Phase II"
"We HAVE to get this cancer grant in before the SBIR program dies!"

You know what's really awesome? The fabulous ZOMG WE GOTTA THROW MONEY AT THIS NOW! mentality of the ARRA means that this brand new packet of funding and its brand new set of requirements I have to learn comes with a proposal deadline of APRIL 27.

Actually, that's the best-case scenario, but applies to the mechanism we really can't use.

It gets better. The supplement application, for which I already have the basic framework of a proposal and budget pulled together (because I rock), is due on APRIL 21. Eeks.

It gets even better, though. At 3 o'clock today, our company president sent me an *urgent* e-mail containing a rough (and I do mean rough) draft of an SBIR proposal that MUST be submitted for the next SBIR deadline because ZOMG the program is gonna die in July if the congresscritters don't save it! That deadline? April 5.

That's right, I get to pull a proposal together on a cancer topic I know nigh on nothing about, in less than 2 weeks. In fact, he wants it done by Monday morning.

And then I have to get another one out within the following two weeks.

While continuing to do ever more development work on the candidate release of our software package and its accompanying website.

Don't worry if your brain just blanked out, mine did, too.

I'm staying up way past my bedtime to figure out how I'm going to make sense of this cancer proposal, and I'm going to try to get to work a little early because I have to give a report on the user testing I performed yesterday. I spent all day on that report and it still isn't finished, but because I'm a scatterbrained idiot, I failed to e-mail it to myself and therefore can't work on it right now.

So instead, I'm just bitching about it and making your eyes glaze over.

Samuel's 2nd birthday is next Thursday and I very much wanted to have a photo album and video put together for it. I don't think it's going to happen. I don't even know how to make the video, and I certainly won't have time to learn it now. I'm a shitty mother. I don't even a birthday party planned for him.

This is so not what I wanted to do with my life. I left academia because I didn't want to spend all my time begging for funding. Yeah. See where that got me?!

Ugh. Back to the grant.
bronwynrh: (Hey handsome)
Samuel has become... difficult, lately. Yes, that's it. Difficult. I think maybe Isabella has sent her No-Sleep Juju down to our house :-( Whereas he used to whimper and whine himself to sleep - or just play quietly until he dropped off to Lala Land, now he screams. He screws himself up and screams through a nearly closed throat so instead of the high-pitched sounds we're used to, we get this pained and desperate, angry sound.

And this only happens when it's bedtime.

Bedtime used to come later, between 8 and 9, but then I read some definitive tome on infant sleep which directed me to bed baby down between 6 and 8. So, we begin the routine at 6 and he's in bed by 7. That worked like a charm for a few weeks, but now it's all gone to crap and I don't know why.

So we're exhausted and frustrated and whereas we're trying our damnedest to ignore him, one of us always gives in. Or make the mistake of thinking he's sound asleep when he's not, or make the further mistake of thinking the other one woke him up so it's ok to interact with him... oh my god. And he's not doing well with our morning routine, either, making much of my home time with him just a blur of desperate and exhausted, rushed hours.

And then I come to work, where my promotion seems to have kicked in before the pay raise. There's a new company - Technologies instead of Laboratories - and it's going to "contract" me out or some such confusing thing, and in spite of what our VP told me, it looks like I'm going to be working for someone instead of with them. Or, rather, the VP is right but this other person hasn't read the memo.

At any rate, new relationships are still being figured out, new responsibilities are still being delegated, and it looks as though I'll be sitting through many, many more meetings. Because meetings are where things get done. Right.

Don't mind me, I shouldn't be complaining about a promotion. I just need a vacation.

And for my kid to remember how to sleep.
bronwynrh: (Don't Panic!)
You're talking on your cellphone while walking through a hallway and, at the end of that hallway, you spot a 7-ft long screen and a Please Do Not Disturb sign in the nook about 20 feet to your left in a side-hall.

Do you:
a) say nothing and continue on your way to the elevator in the main hallway (or back up the hallway from whence you came)?


b) give your cellphone pal a blow-by-blow as you walk up to the screen, comment on the sign and the fact that you hear "a funny noise" coming from behind it and START TO MOVE THE FUCKING SCREEN?

"Excuse me, there's a reason for that sign," I said as I sat behind the screen with my breasts exposed and the pump contraption just starting to do its job.

What the flying fuck, people?!?

The voice was not one I recognize and I didn't have the presence of mind (or slack in the hoses) to stand up to confront the idiot in person. I also couldn't just drop the bottles because I'd wind up covered in milk and there'd be an awful mess. A pumping mother is in an extremely vulnerable position, particularly if she isn't taking any modesty precautions over and above a PRIVACY SCREEN and DO NOT DISTURB sign.

And oh yes. A lactating mother must be relaxed in order to express milk. This is a basic rule of physiology. How relaxed do you think I was after this episode?

Not wanting to inform the entire MedCenter world about what we're doing behind our privacy screen, I made the following alteration to our sign:

Private Area
In Use
Do Not Disturb

I resisted the temptation to add the unprofessional, "This Means You, You Nosy Fuck!"

Of course one must be careful lest one find herself forced to make her baby's lunch in a toilet stall.

In other news, that 7 foot long screen did not pass inspection by the building manager who, I'm told, threw an unprofessional (by my supervisor's standards) e-mail fit in which she threatened to rescind her approval of the space and gave an ultimatum: Replace the screen with a furniture-quality (a new criterion) one, approved by Me by August 15 or I will throw your (functional but not up to spec) screen out in the dumpster.

Awesome. Just watch her pick the most expensive one we come up with. Furniture-quality screens are expensive - and we need two of them to cover the full 7 feet.

bronwynrh: (Don't Panic!)
Although this isn't the most scientific way to gauge my own rationality on the issue, I ask you to help me out. Guys, just imagine you could express milk and tell me what you think.

Oops, meant to cut this )

My last question is this - do I wait to see what they do with that toilet stall, or tell them now that I will not under any circumstances accept that as an appropriate location? In other words, am I being irrational and should wait and see, or am I completely rational and should tell them what to do with their toilet stall?

x-posted for improved sampling size


Jun. 29th, 2007 09:37 am
bronwynrh: (Default)
What a difference! In just a month, he's changed so much. In the icon, he's two months old, and he's three months old this week.

I still look at him in awe... so in love.

Baby milestones and diaper talk )

TGIF! We'll have a whole two days together :)

Tonight, Jeff's staying at a hotel in Nowhere, Indiana to take care of a troubled store. It'll be the first night in forever that we have been apart and I'll miss him, but maybe if the baby sleeps in the bed with me, I won't get too lonely.

As for the pumping-at-work situation... )

Speaking of which, it's time to go down to the temporary dairy and then maybe compose some more grant documents.
bronwynrh: (24)
these aren't options the building manager is presenting us with. Rather, these are well-maybes she's casually bandying about. My supervisor and the other ladies' supervisor are going to have to play liaison for us, which also sucks, because I like to fight my own fights.

In the meantime, I pump in the soon to be otherwise occupied office, my back to the window, wondering just how uncomfortable I'm making people. No. Wondering how uncomfortable some people are choosing to be.

I'll happily take that conference room closet. It's got big steam pipes on one wall (so it's warm), a table, chair, outlet, no windows, and flats upon flats of Cokes, paper plates and napkins. Perfect! Seriously! So long as we can walk through the conference room to the closet whenever we need to do so, it's all good.

But no V, we're not going to schedule our sessions so that we're all pumping together. Much as we may feel like dairy cows at times, we don't want to feel that we're actually in a dairy. Besides which, we'd probably blow a circuit. Thanks anyway.

Alright, I'll stop bitching. For now O_o

No wait. One more gripe. Elljay's comment notification thingamabob is running slower than molasses in wintertime.

Okay, now I'm done.
bronwynrh: (Ack!)
1. This is second-hand, but apparently the sound of our breastpumps is "distracting" people. The person then backtracked, hemming and hawing about "know it's natural, but..."
2. Ok, then why are you making us pump in a cubicle that is one of 4 in a group, the other three occupied by MEN?
3. We could do it in the offices within our laboratories.
4. Key word, lady, is "laboratories". Hello, OSHA? There's a chick makin' like a cow in our lab, is that ok? No? You're shutting us down? Oh, shit. Hello, CLIA? ditto ditto ditto.
5. We could do it in the handicap stall of the bathroom.
6. Operative word here, and I grant it's implied, is "toilet". Also no power outletthe power outlet is 6 inches from the toilet seat, no table, no chair. Have you ever seen a breastpump? Do you know how they work? Ok, well I'll show you and then you'll understand why your idea is ludicrous.
7. Also, EW!
8. I'm one of two women who are pumping. A third woman is pregnant and plans to pump. Apparently this makes us qualify for "you guys" status, and this sudden explosion of pumps is distressing to some.
9. Again with the "then give us a cubicle way the hell over there and get a white noise generator for chrissakes" suggestion.
10. We could do it in the closet of the main conference room.
11. And, if there's someone having a meeting, can I just waltz in and go into the closet? If I'm in the closet and someone starts a meeting, can I just waltz on out? No? Then try again.

Yes, I understand they are under no obligation to do anything for us. I know that. You know what this tells me, though? It tells me they're jerks because they'd rather say, "I don't have to help you, so I won't" than say, "I don't have to help you, but I want to, so I will".

Also, I still don't understand people's hangups about breastfeeding. Ok, you don't want to watch me do it, fine. But to gripe because you can hear the pump and you know what's going on and that makes you uncomfortable? What the frack? These aren't toys, you know. This isn't fun for me. This is what I have to do. Get over yourself.

I'm angry, and trying not to be.
I'm failing.
bronwynrh: (Pregnant)
This blows. I was just informed that the empty office I've been using for my dairy cow sessions will no longer be unoccupied as of some time in July. Although this office had a wall of windows, the windows are nicely frosted and I can sit at the corner of the desk with my back to the world. The curve in the desk was also very handy for pressing the pump thingers and my chest against for hands-free pumping. Awkward, yes, but at least I could play Tetris on my cell phone or eat or read something while I pumped. There was even a drawer with a key where I've been leaving the pump during the week so I'm not toting this 10-pound monster up and down and in and out every day.

Now I'm going to be relegated to a cubicle in the middle of the room, with an ovoid table and a sliding door that leaves a 6-inch gap. The only plug is in the corner opposite the door, so I'm essentially forced to face outward. I pumped in there a couple of times, and had to rig a curtain using a clean lab coat and some thumbtacks.

This is far from ideal, but it's the only option I'm being given. Well no it isn't. They said I could do it up here in the lab, but these are people who don't understand that CLIA and OSHA would throw a shit-fit if they found out. Besides which, the only spot up here with a door is an office with nothing but windows for walls. And no blinds. So, no.

This sucks. Hard. I've been able to relax and pump in relative comfort (when you're pumping booju, comfort is always relative) and now I'll be hunched over a table with my hands gripping the damned thingers and constantly glancing up at the gap in the door to make sure the coat isn't slipping.

Goddammit I'd almost rather go do it in my fucking car.

One more reason why I hate that I have to work.
bronwynrh: (compass)
It's a funny thing about working full-time with a job like mine... I got more done and worked more efficiently working part-time than I do working full-time.

I strongly suggest you skip the incoherent work-related rambling within. )

All of the babbling junk behind the cut really says is that I'm stalled out on my current projects and don't want to work on my future projects, so instead I waste time blogging incoherent nonsense and watching the Financial Services Committee hearing on the internet gambling ban... I'd rather be at home playing with the baby and working on my quilt.

I just realized that what I'm really complaining about is a lack of autonomy, control and the authority to do what needs to be done.

Well there we are, then. The mystery of my procrastination has been solved. I feel better now, don't you?
bronwynrh: (Poop!)
"My girlfriend's a terrible wrestler, but you should see her box."


Oh nonononono! Please, keep repeating it!
bronwynrh: (Default)
Joey has lost his chance. His presentation is tomorrow and he has no fucking clue how to do the protocol today, but he's lost his chance at getting help from me.

It's 1:45 and he has not shown up and has been out of phone contact and I need to leave.

I need to go get passport photos and go to the post office. I have starving kitties at home and I look very pretty and dressed up and feminine today because I have run out of clean pants.

I am leaving. Now.

God damn it.



Oh. I also downloaded lots of data onto my computer so I'm taking my work home with me. So there!



*blows kisses*
bronwynrh: (Default)
What the. . . ?

Wha. . . ?

I come to my LJ page to fine it's been dropped back to some icky, yucky, blue-and-white default style? I didn't do that! What the hell? What the fuck?


LJ has really been doofing up lately. I haven't been able to post comments, read comments, follow links. . . it's been a real pain. I suppose this is supposed to make me want to become a paid user, so that I would/could avoid all this trouble, but all it does is piss me off.

And now this fubar-ing with my style. Sheesh.

Now, what style did I have, anyway? It wasn't Foresty kinda. . . that one sucks. Or is it blows? I'm still trying to figure out which is worse.

I'm here at work, 7pm. Everyone left while I was down in the 'scope room. They locked all the doors and turned off all the lights. Which means that basically everyone put in less than 7 hour days today. Niiiiiiice. Joey's still slacking, but at this point, I've almost given up. There's only so much pep talk I'm willing to give. He's basically taken the school's money, given himself summer camp in return, and will never, ever get a recommendation from either me or Clay. *self-righteous nod*

So, I'm going to autoclave a bunch of test tubes and pipet tips now. Why? Because a certain someone didn't do their job last week, that's why. And while that's happily steaming away, I'll work on building a figure for my paper. If I'm lucky, I'll be home by 10 tonight.

In happier news, I saw Adam in the 'scope room this evening. With the lights on :-)
I won't say that when it rains, it pours, because that would require something to happen, which it hasn't. I'll just say it's nice to feel like a girl again, especially when I spend so much time feeling like a wound-up ball of stressalicious tension.

I'm supposed to go to this dinner with all the summer REU students (ie Joey and cohorts) this Friday, but I'd really rather do something else. Clay has said "you should go, Bronwyn" but I really don't wanna. Would a date be a good enough excuse? Hmmmmm *ponderponderponder* Urf. The Guilt Force. *AIEEE* It is so strong within me! I'll go and get free food and find fun for Saturday.


Duty calls.


Jul. 8th, 2003 02:56 pm
bronwynrh: (Default)
Ok, so I just spent an hour - AN HOUR - talking with Clay about my student and things he can work on and do on his project.

I come out of the office. . . the student is gone. Disappeared.

Has he been around today?


May I ask how I'm supposed to talk with this student? How I'm supposed to work with this student if HE'S NOT AROUND?!?!


Maybe I'll call him and tell him to come back. He has work to do.

Let's add insult to injury, shall we?
I can't reach Joey, because he's not in his dorm room. That's because he's treating his summer like a summer vacation and not like the intensive summer reasearch program it really is.

After all this, I went back downstairs to the microscope room, the ice box, to find that somebody else had signed up for the rest of the afternoon on the computer in my absence. So, not only did I lose the last hour I had reserved for myself because I was talking with Clay about Joey (who had gone AWOL), but I can't go back to working on it at all today. At least, not that end. And I was *this close* to being finished.



bronwynrh: (Default)

February 2012

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