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<tr class="odd">
<td colspan="2"></td>
<td colspan="14"><strong>FORM APPROVED: OMB No. 0910- 0052.</strong>
<strong>Expiration Date: March 31, 2009. See Instructions for OMB
Statement.</strong></td>
</tr>
<tr class="even">
<td colspan="2"><p><strong>DEPARTMENT OF HEALTH AND HUMAN
SERVICES</strong></p>
<p>FOOD AND DRUG ADMINISTRATION</p>
<h1 id="blood-establishment-registration-and-product-listing">BLOOD
ESTABLISHMENT REGISTRATION AND PRODUCT LISTING</h1></td>
<td colspan="3"><p>1. <strong>REGISTRATION NUMBER</strong></p>
<p>FEI :      </p>
<p>CFN:      </p>
<p>2. <strong>U. S. LICENSE NUMBER</strong></p>
<p>     </p></td>
<td colspan="5"><p>3. <strong>REASON FOR SUBMISSION</strong></p>
<p>.1 ANNUAL REGISTRATION</p>
<p>.2 INITIAL REGISTRATION</p>
<p>.3 CHANGE IN INFORMATION</p></td>
<td colspan="6" rowspan="2"><p><strong>FOR FDA USE ONLY</strong></p>
<p>DISTRICT OFFICE:</p></td>
</tr>
<tr class="odd">
<td>PLEASE READ INSTRUCTIONS CAREFULLY. Be sure to indicate any changes
in your legal<br />
name or actual location in item 4, and any changes in your mailing
address in item 6. Print all<br />
entries and make all corrections in red ink, if possible. Enter your
phone number in item 8.3 and<br />
the phone number of your actual location in item 4.1. Sign the form and
return to FDA. After<br />
validation, you will receive your Official Registration for the ensuing
year.</td>
<td colspan="9">This form is authorized by Sections 510( b), (j) and 704
of the Federal Food, Drug, and Cosmetic Act (Title 21, United States
Code 360( b), (j) and 374). Failure to report this information is a
violation of Section 301( f) and (p) of the Act (Title 21, United States
Code 331( f) and (p)) and can result in a fine of up to $1,000 or
imprisonment up to one year or both, pursuant to Section 303( a) of the
Act (Title 21, United States Code 33.3( a)).</td>
</tr>
<tr class="even">
<td><strong>ENTER ALL CHANGES IN RED INK AND CIRCLE.</strong></td>
<td colspan="3">9. <strong>TYPE OF OWNERSHIP.</strong></td>
<td colspan="12">10. <strong>TYPE ESTABLISHMENT</strong> (Check all
boxes that describe routine or autologous operations.)</td>
</tr>
<tr class="odd">
<td rowspan="30"><p>4. <strong>LEGAL NAME AND LOCATION</strong> (Include
legal name, number and street, city,</p>
<p>state, country, and post office code)</p>
<blockquote>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
</blockquote>
<p>4.1 PHONE (     )     -     </p>
<p>5. <strong>OTHER NAMES USED AT THIS LOCATION</strong> (Include trade
name, doing- business- as, previous names, and other firms co- located.
If applicable, include registration number.)</p>
<blockquote>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
</blockquote>
<p>6. <strong>MAILING ADDRESS OF REPORTING OFFICIAL</strong> (Include
institution name if</p>
<p>applicable, number and street, city, state, country, and post office
code)</p>
<blockquote>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
</blockquote>
<p>7. <strong>U. S. AGENT</strong> (Include name, institution name if
applicable, number and street, city, state, and zip code)</p>
<blockquote>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
<p>     </p>
</blockquote>
<p>7.1 E- MAIL ADDRESS      </p>
<p>7.2 PHONE (     )     -     </p>
<p>8. <strong>REPORTING OFFICIAL’S SIGNATURE</strong></p>
<p>8.1 TYPED NAME      </p>
<p>8.2 E- MAIL ADDRESS     </p>
<p>8.3 PHONE (     )     -      8.4 DATE      </p></td>
<td colspan="3" rowspan="3"><p>.1 SINGLE PROPRIETORSHIP</p>
<p>.2 PARTNERSHIP</p>
<p>.3 CORPORATION profit non- profit </p>
<p>.4 COOPERATIVE ASSOCIATION</p>
<p>.5 FEDERAL (non- military)</p>
<p>.6 U. S. MILITARY</p>
<p>.7 STATE</p>
<p>.8 COUNTY/ MUNICIPAL/ HOSPITAL AUTHORITY</p>
<p>.9 OTHER (Specify):      </p></td>
<td colspan="12"><p>.1 COMMUNITY (NON- HOSPITAL) BLOOD BANK</p>
<p>.2 HOSPITAL BLOOD BANK</p>
<p>.3 PLASMAPHERESIS CENTER</p>
<p>.4 PRODUCT TESTING LABORATORY</p>
<p>a. INDEPENDENT</p>
<p> ASSOCIATED W/ COMMUNITY or HOSPITAL BLOOD BANK</p>
<p>.5 HOSPITAL TRANSFUSION SERVICE</p>
<p>a. APPROVED FOR MEDICARE REIMBURSEMENT</p>
<p> NOT APPROVED FOR MEDICARE REIMBURSEMENT</p>
<p>.6 COMPONENT PREPARATION FACILITY</p>
<p>.7 COLLECTION FACILITY      </p>
<p>.8 DISTRIBUTION CENTER U. S. LICENSE NUMBER OF PARENT FIRM</p>
<p>.9 BROKER/ WAREHOUSE</p></td>
</tr>
<tr class="even">
<td colspan="3">.10 OTHER (Specify):</td>
<td colspan="8">     </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="12"></td>
</tr>
<tr class="even">
<td colspan="2">11. <strong>PRODUCTS</strong></td>
<td colspan="2" rowspan="2">COLLECT</td>
<td rowspan="2"><p>MANUAL</p>
<p>APHERESIS</p></td>
<td colspan="2" rowspan="2"><p>AUTOMATED</p>
<p>APHERESIS</p></td>
<td rowspan="2">PREPARE</td>
<td colspan="2" rowspan="2"><p>LEUKOCYTES</p>
<p>REDUCED</p></td>
<td rowspan="2">IRRADIATED</td>
<td rowspan="2"><p>DONOR</p>
<p>RETESTED</p></td>
<td rowspan="2">TEST</td>
<td colspan="2" rowspan="2"><p>STORE and</p>
<p>DISTRIBUTE</p>
<p>to OTHERS</p></td>
</tr>
<tr class="odd">
<td colspan="2" rowspan="2"><p> </p>
<p>ALLOGENEIC AUTOLOGOUS DIRECTED</p></td>
</tr>
<tr class="even">
<td colspan="2">(. 1)</td>
<td>(. 2)</td>
<td colspan="2">(. 3)</td>
<td>(. 4)</td>
<td colspan="2">(. 5)</td>
<td>(. 6)</td>
<td>(. 7)</td>
<td>(. 8)</td>
<td colspan="2">(. 9)</td>
</tr>
<tr class="odd">
<td colspan="2">WHOLE BLOOD 1</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">RED BLOOD CELLS (RBC) 2</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">RBC FROZEN 3</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">RBC DEGLYCEROLIZED 4</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">RBC REJUVENATED 5</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">RBC REJUVENATED FROZEN 6</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">RBC REJUVENATED DEGLYCEROLIZED 7</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">CRYOPRECIPITATED AHF 8</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">PLATELETS 9</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">LEUKOCYTES / GRANULOCYTES 10</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">PLASMA 11</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">PLASMA CRYOPRECIPITATE REDUCED 12</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">FRESH FROZEN PLASMA 13</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">LIQUID PLASMA 14</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">THERAPEUTIC EXCHANGE PLASMA 15</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">SOURCE LEUKOCYTES 16</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">SOURCE PLASMA 17</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">RECOVERED PLASMA 18</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">BLOOD PRODUCTS FOR DIAGNOSTIC USE 19</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">BLOOD BANK REAGENTS 20</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">OTHER       21</td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
</tr>
</tbody>
</table>

+-----------------------------------+-----------------------------------+
| INSTRUCTIONS FOR COMPLETING BLOOD |                                   |
| REGISTRATION FORM 2830            |                                   |
+-----------------------------------+-----------------------------------+
| These instructions will help you  | **.3 Plasmapheresis Center- -**   |
| complete FDA 2830. The FDA        | An establishment licensed by the  |
| requires all blood establishments | FDA/ CBER that collects Source    |
| that collect,\                    | Plasma or Therapeutic\            |
| manufacture, prepare, store under | Exchange Plasma for commercial    |
| controlled conditions for further | distribution. If you also collect |
| distribution, or process blood    | Whole Blood for a licensed        |
| and blood products to\            | establishment, check\             |
| register under Title 21, CFR,     | \"Collection Facility\" and       |
| Part 607. Hospital Transfusion    | include the license number of the |
| Services certified under the      | parent firm. Hospitals that       |
| Medicare program are exempt\      | perform plasmapheresis for        |
| from registration (see 21 CFR     | research purposes only or to      |
| 607.65( f)). We consider          | prepare transfusion products such |
| establishments that perform       | as Plasma or Platelets, Pheresis, |
| certain manufacturing steps to    | should NOT check this box.        |
| be\                               |                                   |
| Hospital Blood Banks, which are   | **.4 Product Testing Laboratory-  |
| required to register. See         | -** A separate establishment that |
| instructions for Item 10.2 for    | performs routine blood and plasma |
| these manufacturing steps.        | donor testing. You\               |
|                                   | must also answer Item 10.4a       |
| Please review all pre- printed    | concerning type establishment.    |
| data for accuracy and             |                                   |
| completeness. Circle incorrect    | **.5 Hospital Transfusion         |
| items in RED INK, and PRINT all\  | Service- -** A hospital that      |
| corrections and additions.        | performs compatibility testing    |
|                                   | (crossmatching) for blood or      |
| Note the following: YOU MUST      | blood components but does NOT     |
| NOTIFY FDA WITHIN 5 DAYS IF YOU   | routinely collect allogeneic or   |
| CHANGE LOCATION.                  | autologous blood, or process      |
|                                   | Whole Blood into components       |
| **Item 2. U. S. LICENSE NUMBER-   | (except Red Blood Cells and       |
| -** The FDA Center for Biologics  | Recovered Plasma). We consider    |
| Evaluation and Research (CBER)    | hospitals that freeze,            |
| issues U. S. Licenses under       | deglycerolize, wash, irradiate,   |
| section 351 of the Public Health  | rejuvenate, or reduce the number  |
| Service Act to firms that apply   | of leukocytes from Red Blood      |
| for licensure and otherwise       | Cells to be Hospital Blood Banks  |
| qualify. Licenses are appropriate | (Item 10.2). You must\            |
| only for firms engaged in         | also answer Item 10.5a concerning |
| *interstate* commerce. Only Blood | Medicare program reimbursement.   |
| Banks, Plasmapheresis Centers,    |                                   |
| Product Testing Laboratories, and | **.6 Component Preparation        |
| others are assigned unique        | Facility- -** An intermediate     |
| license numbers. If your          | processing establishment that     |
| establishment is licensed, your   | prepares components from blood\   |
| U. S. License number appears in   | collected by a mobile or fixed    |
| item 2 for your major             | collection site but does not      |
| manufacturing facilities.         | perform product testing. If       |
| Establishments such as Component  | applicable, indicate the license\ |
| Preparation\                      | number under which the component  |
| Facilities, Collection            | preparation facility operates. If |
| Facilities, and Distribution      | you also collect or redistribute, |
| Centers that operate under the    | check Item 10.7 or\               |
| license of a parent establishment | 10.8.                             |
| have the parent U. S. License     |                                   |
| number next to Item 10.7.         | **.7 Collection Facility- -** An  |
|                                   | establishment that performs blood |
| **Item 4. LEGAL NAME AND          | collections or apheresis, but     |
| LOCATION- -** Provide the legal   | does not test. If applicable,\    |
| name (not the \"doing- business-  | indicate the U. S. License number |
| as\" or other names in Item 5),   | under which the collection        |
| street address, and telephone     | facility operates. If you also    |
| number of the actual location.    | redistribute the final product    |
| Include the postal code (and, for | after it has been processed and   |
| U. S. firms, the 4- digit ZIP     | returned to you by the blood      |
| code extension). NOTE: If blood   | bank, then check Distribution     |
| collection and laboratory         | Center, check Item 10.8.          |
| facilities are separated, but     |                                   |
| register as one establishment\    | **.8 Distribution Center- -** An  |
| because of their close proximity, | establishment that stores blood   |
| use the laboratory address.       | or blood products FOR TRANSFUSION |
|                                   | under specific controlled         |
| **Item 5. OTHER NAMES USED AT     | conditions prior to shipping it   |
| THIS LOCATION- -** Provide any    | to the final user. A transfusion  |
| other name by which your facility | service is not typically          |
| is commonly known, including any  | considered to be a\               |
| name not shown in Item 4, that is | \"distribution center\" since it  |
| or was used at this location.     | holds the product over a          |
| This includes trade, doing-       | relatively short period of time   |
| business- as, and previous names, | and does not intend to            |
| and names of unaffiliated         | redistribute. If\                 |
| corporations at the same          | you are a transfusion service     |
| location. If registered with FDA, | operating as a depot or           |
| include the registration number   | distribution center for a blood   |
| in parentheses.                   | bank, register as a Distribution  |
|                                   | Center and include the license    |
| **Item 6. MAILING ADDRESS OF      | number of the blood bank, if      |
| REPORTING OFFICIAL- -** Provide   | licensed.                         |
| the reporting official's mailing  |                                   |
| address if it is different from   | **.9 Broker/ Warehouse- -** A     |
| the actual location of the        | broker, distributor, or warehouse |
| establishment. Include the postal | that stores and redistributes     |
| code (and, for U. S. firms, the   | source material for further       |
| 4- digit ZIP code extension).     | manufacture, such as Recovered    |
|                                   | Plasma, Source Plasma, and whole  |
| **Item 7. U. S. AGENT- -** Non-   | blood, red blood cells, or        |
| U. S. establishments only:        | platelets for diagnostic product  |
| Provide your U. S. agent name,    | use.                              |
| institution name if applicable,   |                                   |
| street address, e- mail address,  | **.10 Other (specify) - -** This  |
| and telephone number.             | includes firms that manufacture   |
|                                   | fractionated blood derivatives,   |
| **Item 8. REPORTING OFFICIAL'S    | diagnostics, and other blood      |
| SIGNATURE- -** The reporting      | products, or independent          |
| official is the person appointed  | establishments that irradiate     |
| by the owner or operator\         | blood products.                   |
| to register the firm and answer   |                                   |
| all letters and inquiries about   | **11. PRODUCTS- -** Check all     |
| registration. Include the         | products that you manufacture in  |
| reporting official's e- mail      | the appropriate columns. This     |
| address and telephone number.     | includes allogeneic, autologous,  |
|                                   | and directed collections, or      |
| **Item 10. TYPE ESTABLISHMENT-    | products prepared, tested, or     |
| -** Check all applicable boxes    | stored for distribution to other  |
| that describe your routine or     | firms. See the\                   |
| autologous operations. If\        | Product Definition section for    |
| you check Hospital Transfusion    | information on products. **Do not |
| Service (10.5) do not check any   | fill in shaded areas.** You must  |
| other block. If you operate as an | list, in 11.21 \"Other,\" any     |
| auxiliary establishment (e. g., a | product you manufacture that is   |
| donor center) for a Community or  | not specified in the product      |
| Hospital Blood Bank, check blocks | list. Do not list products held   |
| 10.6 through 10.8 as applicable.  | for final use, such as albumin,   |
| If your parent blood bank is      | reagents, immune globulins, etc.  |
| licensed, include the parent      |                                   |
| license number. NOTE: There is    | Do not list any products you      |
| now a line for component brokers, | collect as a by- product of a     |
| independent distributors, and     | therapeutic procedure and         |
| warehouses.                       | immediately destroy. Similarly,   |
|                                   | exclude products prepared under   |
| **.1 Community (Non- hospital)    | emergency conditions. We define   |
| Blood Bank- -** A commercial or   | an emergency as a situation that  |
| non- profit blood collection/     | demands immediate action that has |
| processing establishment, not     | been suitably documented in       |
| located in a hospital, that may   | writing by a responsible person.  |
| perform product testing and       | Do not list products that are     |
| routinely distributes blood and/  | pooled or divided into pediatric  |
| or blood products to one or\      | aliquots. A completed FDA 2657,   |
| more hospitals. We consider an    | \"Drug Product Listing,\" or FDA  |
| independent blood bank located    | 2892, \"Medical Device Listing,\" |
| inside a hospital, but separately | must be submitted for any product |
| operated and owned, to\           | not previously listed with FDA in |
| be a Hospital Blood Bank (Item    | order that an NDC Labeler Code    |
| 10.2).                            | may be assigned.                  |
|                                   |                                   |
| .2 Hospital Blood Bank- - A       | If you collect blood, indicate    |
| hospital (or establishment        | Allogeneic, Autologous, or        |
| located within a hospital) that   | Directed donor classifications.   |
| routinely collects or processes   | Allogeneic collections are        |
| Whole Blood or blood components.  | intended for transfusion to other |
| Components may be collected by    | than the donor or a known         |
| apheresis or prepared from Whole  | recipient. Autologous collections |
| Blood. Processing includes        | are intended for transfusion at a |
| freezing, deglycerolizing,        | later time to the donor. Directed |
| washing, irradiating,             | collections are intended for      |
| rejuvenating, or leukocyte-       | transfusion to a known recipient. |
| reducing Red Blood Cells. We      |                                   |
| include hospitals that perform    | (. 1) **Collect- -** refers to    |
| autologous or directed            | collection of whole blood or      |
| collections in this category.     | blood products for transfusion or |
| Hospital Blood Banks usually      | further manufacturing into        |
| perform product testing (such as  | injectable or non-injectable      |
| blood grouping and hepatitis      | products.                         |
| testing), as well as              |                                   |
| compatibility testing. We         | (. 2) **Manual Apheresis- -**     |
| consider hospitals that solely    | refers to procedures such as      |
| prepare Red Blood Cells or        | plasmapheresis, plateletpheresis, |
| Recovered Plasma, pool Platelets  | and leukapheresis, in which       |
| or Cryoprecipitated AHF for ease  | unneeded portions of the whole    |
| of transfusion, or issue bedside  | blood are returned to the donor.  |
| leukocyte- reduction filters with |                                   |
| blood components to be Hospital   | (. 3) **Automated Apheresis- -**  |
| Transfusion Services (Item 10.5). | refers to the collection of Red   |
| A hospital that collects Source   | Blood Cells, Platelets,           |
| Plasma under licensure should     | Leukocytes, Granulocytes, or      |
| also check \"Plasmapheresis       | Plasma by automated equipment.    |
| Center.\"                         |                                   |
+-----------------------------------+-----------------------------------+

+-----------------------------------+-----------------------------------+
| **INSTRUCTIONS FOR COMPLETING     |                                   |
| BLOOD REGISTRATION FORM 2830      |                                   |
| (Continued)**                     |                                   |
+-----------------------------------+-----------------------------------+
| (. 4) **Prepare\--** refers to    | .11 **Plasma- -** The fluid       |
| functions such as component       | portion of one unit of human      |
| preparation from Whole Blood. For | blood intended for transfusion    |
| example, if you prepare Platelets | which, in a closed system, has    |
| from Whole Blood, check box 9(.   | been collected, stabilized        |
| 4). If you collect Platelets by   | against clotting, and separated   |
| automated apheresis, check box    | from red cells within 26 days     |
| 9(. 3). Check box 9(. 2) for      | after phlebotomy (40 days when    |
| Platelets collected by manual     | CPDA- 1 is used as the            |
| apheresis.                        | anticoagulant) and stored at      |
|                                   | -18°C or colder.                  |
| (. 5) **Leukocytes Reduced\--**   |                                   |
| refers to blood products          | .12 **Plasma Cryoprecipitate      |
| processed to remove leukocytes    | Reduced- -** Plasma from which    |
| before issue. Leukocyte- reduced  | Cryoprecipitated AHF has been     |
| products should meet the criteria | removed.                          |
| for residual leukocyte count and  |                                   |
| product recovery described in FDA | .13 **Fresh Frozen Plasma- -**    |
| recommendations. Do not include   | Single donor plasma prepared from |
| products leukocyte reduced during | Whole Blood within 8 hours of     |
| transfusion.                      | collection, or collected by       |
|                                   | automated apheresis, and stored   |
| (. 6) **Irradiated\--** refers to | at -18°C or colder.               |
| irradiation of blood products     |                                   |
| before transfusion. Check this    | .14 **Liquid Plasma- -** Single   |
| only if you are performing the    | donor plasma separated from red   |
| irradiation step, or have a       | cells within 26 days after        |
| contract manufacturing agreement  | phlebotomy (40 days when CPDA- 1  |
| for another establishment to      | is used as the anticoagulant) and |
| perform the irradiation for you.  | stored at 1- 6°C.                 |
|                                   |                                   |
| (. 7) **Donor Retested\--**       | .15 **Therapeutic Exchange Plasma |
| refers to storage of products for | (TEP)- -** Plasma obtained from a |
| a minimum of 112 days, until the  | patient who undergoes plasma      |
| donor returns for subsequent      | exchange (also called therapeutic |
| donation or testing, and all      | plasmapheresis). Do not list TEP  |
| infectious disease markers are    | that is destroyed immediately.    |
| negative at the subsequent        | TEP is intended as a source       |
| testing.                          | material for further              |
|                                   | manufacturing use, and may not be |
| (. 8) **Test\--** refers to       | distributed without a license.    |
| product testing such as blood     |                                   |
| grouping, syphilis, hepatitis,    | .16 **Source Leukocytes- -**      |
| HIV, and protein electrophoresis, | White Blood Cells intended as     |
| as well as compatibility testing  | source material for further       |
| (crossmatching). It does not      | manufacturing use.                |
| include daily quality control     |                                   |
| tests of reagents.                | .17 **Source Plasma- -** The      |
|                                   | fluid portion of human blood      |
| (. 9) **Store and Distribute to   | collected by plasmapheresis       |
| Others\--** refers to storage of  | (except plasma derived by         |
| products under controlled         | therapeutic plasma exchange) and  |
| conditions for distribution to    | intended as a source material for |
| other firms.                      | further manufacturing use. This   |
|                                   | includes source material intended |
| THE REPORTING OFFICIAL MUST SIGN  | for injectable and non-           |
| AND DATE THIS FORM. After         | injectable products.              |
| completion, send the form to:     |                                   |
|                                   | .18 **Recovered Plasma- -**       |
| **Food and Drug Administration\   | Plasma derived from single units  |
| Center for Biologics Evaluation   | of Whole Blood, Plasma, or as a   |
| and Research (HFM- 370)\          | by- product in the preparation of |
| ATTENTION: Blood Registration     | blood components from Whole       |
| Coordinator\                      | Blood, for use in the             |
| 1401 Rockville Pike, 200N\        | manufacturing of licensed or      |
| Rockville, MD 20852- 1448**       | unlicensed products.              |
|                                   |                                   |
| After we update your registration | .19 **Blood Products for          |
| form, we will send a validated    | Diagnostic Use- -** Whole Blood,  |
| form to the location shown for    | Red Blood Cells, or Platelets     |
| the registering establishment,    | shipped for further manufacture   |
| and to you if your address is     | into non- injectable products.    |
| different. If you have questions, |                                   |
| contact the Blood Registration    | .20 **Blood Bank Reagents- -**    |
| Coordinator at 301- 827- 3546, or | Diagnostic substances             |
| by e- mail at \<bloodregis@ cber. | manufactured for commercial       |
| fda. gov\>.                       | distribution used to characterize |
|                                   | and determine the acceptability   |
| #### PRODUCT DEFINITION           | of blood or products for          |
|                                   | transfusion purposes. These       |
| .1 **Whole Blood- -** All blood   | include reagent Red Blood Cells,  |
| collected from human donors for   | blood grouping reagents, antibody |
| transfusion to human recipients   | to HBsAg, etc. A separate FDA     |
| using an approved anticoagulant   | 2892, \"Medical Device Listing,\" |
| preservative solution.            | should be submitted for each      |
|                                   | product when a product is         |
| .2 **Red Blood Cells- -** Red     | initially listed.                 |
| Blood Cells remaining after       |                                   |
| separating plasma from human      | .21 **Other- -** Other products   |
| blood, or collected by\           | not listed above that you         |
| apheresis.                        | manufacture for commercial        |
|                                   | distribution. This includes       |
| .3 **RBC Frozen- -** Red Blood    | fractionated blood derivatives    |
| Cells stored at ultra- low        | such as immune globulins,         |
| temperature in the presence of a  | albumin, etc. Do not list these   |
| cryoprotective agent, which may   | products if you do not            |
| be preserved for long periods of  | manufacture them. When submitting |
| time.                             | an initial product listing, list  |
|                                   | each product individually on the  |
| .4 **RBC Deglycerolized- -** Red  | FDA 2657, \"Drug Product          |
| Blood Cells washed free of the    | Listing\".                        |
| glycerol in which they have been  |                                   |
| stored.                           | February, 2003                    |
|                                   |                                   |
| .5 **RBC Rejuvenated- -** Red     | #####                             |
| Blood Cells treated with a        | Paperwork Reduction Act Statement |
| rejuvenating solution, such as    |                                   |
| pyruvate inosine, to restore cell | An Agency may not conduct or      |
| integrity.                        | sponsor, and a person is not      |
|                                   | required to respond to, a         |
| .6 **RBC Rejuvenated Frozen- -**  | collection of information unless  |
| Red Blood Cells treated with a    | it displays a currently valid OMB |
| rejuvenating solution, then       | control number. Public reporting  |
| frozen and stored at\             | burden for this collection of     |
| ultra-low temperatures in the     | information is estimated to       |
| presence of a cryoprotective      | average 15 minutes per response   |
| agent.                            | for product listing updates, 1    |
|                                   | hour for initial registration,    |
| .7 **RBC Rejuvenated              | and 30 minutes for                |
| Deglycerolized- -** Red Blood     | re-registration, including time   |
| Cells treated with a rejuvenating | for reviewing instructions,       |
| solution, frozen using a\         | searching existing data sources,  |
| cryoprotective agent, and then    | gathering and maintaining the     |
| washed free of the rejuvenating   | necessary data, and completing    |
| solution and glycerol.            | and reviewing the collection of   |
|                                   | information. Send comments        |
| .8 **Cryoprecipitated AHF- -** A  | regarding this burden estimate or |
| preparation containing            | any other aspect of this          |
| antihemophilic factor obtained    | collection of information to:     |
| from a single unit of plasma.     |                                   |
|                                   | > Food and Drug Administration    |
| .9 **Platelets - -** Platelets    | >                                 |
| collected from a single donor and | > Center for Biologics Evaluation |
| suspended in a specified volume   | > and Research (HFM- 370)         |
| of original plasma.               | >                                 |
|                                   | > ATTENTION: Blood Registration   |
| .10 **Leukocytes/ Granulocytes-   | > Coordinator                     |
| -** White Blood Cells             | >                                 |
| (leukocytes) collected from a     | > 1401 Rockville Pike, 200N       |
| single donor and suspended in a   | >                                 |
| specific volume of original       | > Rockville, MD 20852- 1448       |
| plasma intended for patient       |                                   |
| infusion.                         |                                   |
+-----------------------------------+-----------------------------------+