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Dockets Management
Dockets Entered On June 18, 2004
Table of Contents
Docket # Title
1997N-0484S Human Cellular and Tissue-Based Products
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
2004N-0221 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
2004Q-0180 Qualified Health Claim (QHC): Lutein and Eye Diseases
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
EC 2 Ms. Lisa Byrne >Vol #: 5
1997N-0484S Human Cellular and Tissue-Based Products
REF 1 Reference >Vol #: 44
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 134 Center for Veterinary Medicine >Vol #: 412
EXB 135 Center for Veterinary Medicine >Vol #: 412
EXB 136 Center for Veterinary Medicine >Vol #: 412
EXB 137 Center for Veterinary Medicine >Vol #: 412
EXB 138 Center for Veterinary Medicine >Vol #: 412
EXB 139 Center for Veterinary Medicine >Vol #: 412
EXB 140 Center for Veterinary Medicine >Vol #: 412
EXB 141 Center for Veterinary Medicine >Vol #: 412
EXB 142 Center for Veterinary Medicine >Vol #: 412
EXB 143 Center for Veterinary Medicine >Vol #: 412
EXB 144 Center for Veterinary Medicine >Vol #: 412
EXB 145 Center for Veterinary Medicine >Vol #: 412
EXB 146 Center for Veterinary Medicine >Vol #: 412
EXB 147 Center for Veterinary Medicine >Vol #: 413
EXB 148 Center for Veterinary Medicine >Vol #: 413
EXB 149 Center for Veterinary Medicine >Vol #: 413
EXB 150 Center for Veterinary Medicine >Vol #: 413
EXB 151 Center for Veterinary Medicine >Vol #: 413
EXB 152 Center for Veterinary Medicine >Vol #: 413
EXB 153 Center for Veterinary Medicine >Vol #: 413
EXB 154 Center for Veterinary Medicine >Vol #: 413
EXB 155 Center for Veterinary Medicine >Vol #: 413
EXB 156 Center for Veterinary Medicine >Vol #: 413
EXB 157 Center for Veterinary Medicine >Vol #: 414
EXB 158 Center for Veterinary Medicine >Vol #: 414
EXB 159 Center for Veterinary Medicine >Vol #: 414
EXB 160 Center for Veterinary Medicine >Vol #: 414
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 1454 J and S Lancour >Vol #: 274
C 1455 K. Davis >Vol #: 274
C 1456 D. Gale >Vol #: 274
C 1457 Women's Health Care, PC >Vol #: 274
C 1458 A. Frankforther >Vol #: 274
C 1459 J. Bouillon >Vol #: 274
C 1460 A. Wonder >Vol #: 274
C 1461 I. Grubliauskas >Vol #: 274
C 1462 L and D Thompson >Vol #: 274
C 1463 Illegible >Vol #: 274
C 1464 J. Rooney >Vol #: 274
C 1465 C. Sinforosa >Vol #: 274
C 1466 C Farley and F Carroll >Vol #: 274
C 1467 T. Walter >Vol #: 274
C 1468 M. Michaels >Vol #: 274
C 1469 L and R Bialik >Vol #: 274
C 1470 W. Quinn >Vol #: 274
C 1471 D and A Fiede >Vol #: 274
C 1472 E. Dugan >Vol #: 274
C 1473 D. Guiheen >Vol #: 274
C 1474 D. Campbell >Vol #: 274
C 1475 R. Mancini >Vol #: 274
C 1476 N. Winters >Vol #: 274
C 1477 P. Kuhlman, MD >Vol #: 274
C 1478 B. Johnson >Vol #: 274
C 1479 D. Kluge >Vol #: 274
C 1480 A. Dolgene >Vol #: 275
C 1481 Illegible >Vol #: 275
C 1482 D. Knapp >Vol #: 275
C 1483 G. Heuer >Vol #: 275
C 1484 M. Baron >Vol #: 275
C 1485 Illegible >Vol #: 275
C 1486 P.J. Ensign >Vol #: 275
C 1487 M. Halvorson >Vol #: 275
C 1488 T. Amalull >Vol #: 275
C 1489 J. Olson >Vol #: 275
C 1490 B. Mauch >Vol #: 275
C 1491 Eligible >Vol #: 275
C 1492 M. and W. Darst >Vol #: 275
C 1493 J. Rohlik >Vol #: 275
C 1494 Y. Angrisani >Vol #: 275
C 1495 H. Hey >Vol #: 275
C 1496 D. Favinger >Vol #: 275
C 1497 Illegible >Vol #: 275
C 1498 M. Gullion >Vol #: 275
C 1499 M. Barnes >Vol #: 275
C 1500 Illegible >Vol #: 275
C 1501 M. McGrath, PhD >Vol #: 275
C 1502 J. Elliott >Vol #: 275
C 1503 Sister P. Miriam,Msbt >Vol #: 275
C 1504 A and B Tescher >Vol #: 275
C 1505 C. Merkel >Vol #: 275
C 1506 V. Karel >Vol #: 275
C 1507 D. Cary >Vol #: 275
C 1508 F. Hejtmanek >Vol #: 275
C 1509 E and J Prochaska >Vol #: 275
C 1510 Illegible >Vol #: 275
C 1511 J. Heit >Vol #: 375
C 1512 G. Braun >Vol #: 375
C 1513 C. Shuck >Vol #: 275
C 1514 M. Goodrich >Vol #: 275
C 1515 A. Mellody >Vol #: 275
C 1516 M. McGeary >Vol #: 275
C 1517 B. Boblink >Vol #: 275
C 1518 T and B Braun >Vol #: 275
C 1519 V. Fubelli >Vol #: 275
C 1520 R. Mikals >Vol #: 275
C 1521 A. Ludwick >Vol #: 275
C 1522 J. Kulman >Vol #: 275
C 1523 R. Fenichel >Vol #: 275
C 1524 J. Hill >Vol #: 275
C 1525 J. Drinan >Vol #: 275
C 1526 G. Kaplan >Vol #: 275
C 1527 L. Munitz >Vol #: 275
C 1528 I. Dusinberre >Vol #: 275
C 1529 K. Plant >Vol #: 275
C 1530 N. Olsen >Vol #: 275
C 1531 Eligible >Vol #: 275
C 1532 R. Mart >Vol #: 275
C 1533 B. Laudsberger >Vol #: 275
C 1534 J. Harris >Vol #: 275
C 1535 K. Delanoy >Vol #: 275
C 1536 G. Getz >Vol #: 275
C 1537 D. Jones >Vol #: 275
C 1538 P. Lupuneth >Vol #: 275
C 1539 J. Boston >Vol #: 275
C 1540 J. Kirschner >Vol #: 275
C 1541 F. Batzer, MD >Vol #: 275
C 1542 T. Crean >Vol #: 275
C 1543 G. Grigsby >Vol #: 275
C 1544 J. Kirschner >Vol #: 275
C 1545 New York University School of Medicine >Vol #: 275
C 1546 Middlesex Hospital >Vol #: 275
C 1547 A. Klump >Vol #: 275
C 1548 UCLA School of Public Health >Vol #: 275
C 1549 A. Baylson >Vol #: 275
C 1550 T. Bobo, D.O. >Vol #: 275
C 1551 M. Falater >Vol #: 275
C 1552 National Assn of Nurse Practitioners in Women's Health (NPWH) >Vol #: 275
C 1553 Rev. J. Nelson >Vol #: 275
C 1554 R. Neborsky >Vol #: 275
C 1555 F. Hellerman >Vol #: 275
C 1556 F and F Nathan >Vol #: 275
C 1557 M. Farrand >Vol #: 275
C 1558 Rev. J Nelson >Vol #: 275
C 1559 J. Sherman >Vol #: 275
C 1560 M. Falater >Vol #: 275
C 1561 P. Vo >Vol #: 275
C 1562 National assn of Nurse Practitioners in Women's Health (NPWH) >Vol #: 275
C 1563 L. Lupa >Vol #: 275
C 1564 Baystate Medical Center >Vol #: 275
C 1565 University of California, San Francisco >Vol #: 275
C 1566 Emory University School of Medicine >Vol #: 275
C 1567 L. Darling >Vol #: 275
C 1568 F Nathan >Vol #: 275
C 1569 T. Bobo, D.O. >Vol #: 275
C 1570 B. Moxon >Vol #: 275
C 1571 University of Arizona >Vol #: 275
C 1572 Northwestern University >Vol #: 275
C 1573 G. Pla >Vol #: 275
C 1574 M. Copp >Vol #: 275
C 1575 Women's Health Care of Western Colorado, PC >Vol #: 275
C 1576 I and H Freiberger >Vol #: 275
C 1577 Univerity of South Carolina School of Medicine >Vol #: 275
C 1578 National Health Law Program (NHeLP) >Vol #: 275
C 1579 S. Goodman,MD,MPH >Vol #: 275
C 1580 J. Williams >Vol #: 275
C 1581 B. Stovall >Vol #: 276
C 1582 18 signatures >Vol #: 276
C 1583 D. Bouillon >Vol #: 276
C 1584 M. Brennan >Vol #: 276
C 1585 M. Dobbertin >Vol #: 276
C 1586 C. Macaluso >Vol #: 276
C 1587 M. Oliver >Vol #: 276
C 1588 J. Morse >Vol #: 276
C 1589 T. Walsh >Vol #: 276
C 1590 Highlands Center for Women >Vol #: 276
C 1591 J. Portman >Vol #: 276
C 1592 Family Research Council >Vol #: 276
C 1593 K. Smith >Vol #: 276
C 1594 V. Pitrelli >Vol #: 276
C 1595 M. Pavnic >Vol #: 276
C 1596 Women's Life Center >Vol #: 276
C 1597 P. Holmes >Vol #: 276
C 1598 K. Wichmann >Vol #: 276
C 1599 D. McMullin >Vol #: 276
C 1600 Lake County Right to Life >Vol #: 276
C 1601 L. Long >Vol #: 276
C 1602 D. Kirszenberg >Vol #: 276
C 1603 C. Perry, MD >Vol #: 276
C 1604 Maternal-Fetal Medicine, P.C. >Vol #: 276
C 1605 M. Mazanec >Vol #: 276
C 1606 M. Barulich, MD >Vol #: 276
C 1607 N. Ng >Vol #: 276
C 1608 J. Wiechart >Vol #: 276
C 1609 R. Bakley >Vol #: 276
C 1610 D. Lang, D.O., F.A.C.O.O.G. >Vol #: 276
C 1611 R. Frohlich >Vol #: 276
C 1612 M. Gradeless >Vol #: 276
C 1613 J. Kennedy >Vol #: 276
C 1614 A. Trognitz >Vol #: 276
C 1615 J. Backer, FNP, MSN >Vol #: 276
C 1616 W. Davidson,MSN, CNP >Vol #: 276
C 1617 L. Bleich >Vol #: 276
C 1618 P. Hunt >Vol #: 276
C 1619 M. Halloran >Vol #: 276
C 1620 J. Ryland >Vol #: 276
C 1621 D. Meers, ARNP >Vol #: 276
C 1622 D. Warner, LMT >Vol #: 276
C 1623 Advocates for Choice >Vol #: 276
C 1624 A. Brennan >Vol #: 276
C 1625 J. Albright, MPH >Vol #: 276
C 1626 R. King >Vol #: 276
C 1627 D. Lowrie >Vol #: 276
C 1628 S. Ritchie >Vol #: 276
C 1629 V. Eickelberg >Vol #: 276
C 1630 R. Wingo >Vol #: 276
C 1631 M. Keating >Vol #: 276
C 1632 S. Johnson >Vol #: 276
C 1633 D. Haynik >Vol #: 276
C 1634 C. Bright >Vol #: 276
C 1635 T. Thompson >Vol #: 276
C 1636 J. Ramler >Vol #: 276
C 1637 J. Gonzalez >Vol #: 276
C 1638 L. Pekala, LPN >Vol #: 276
C 1639 V. Sillman >Vol #: 276
C 1640 T. Hoglan >Vol #: 276
C 1641 T. Piskator >Vol #: 276
C 1642 J. Davis >Vol #: 276
C 1643 Illegible >Vol #: 276
C 1644 Illegible >Vol #: 276
C 1645 M. Smith >Vol #: 276
C 1646 C. Klein >Vol #: 276
C 1647 M. Campbell >Vol #: 276
C 1648 J. Fletcher, Jr., MD,FAAFP >Vol #: 276
C 1649 Rum River Life Choices Center >Vol #: 276
C 1650 Juridic Embassy >Vol #: 276
C 1651 N. Narine >Vol #: 276
C 1652 J. Glasser, MD >Vol #: 276
C 1653 E and A Dellare >Vol #: 276
C 1654 M. Klusman >Vol #: 276
C 1655 L. Glasford >Vol #: 276
C 1656 A. Besaw >Vol #: 277
C 1657 R. Bedner >Vol #: 277
C 1658 J. Passero >Vol #: 277
C 1659 C. O'Callahan,MD,PhD >Vol #: 277
C 1660 K. Michael, M.D. >Vol #: 277
C 1661 G. Rosenberg >Vol #: 277
C 1662 S. Goodman,MD,MPH >Vol #: 277
C 1663 Illegible >Vol #: 277
C 1664 P. Taylor,CNM,MPH,ARNP >Vol #: 277
C 1665 New York University School of Medicine >Vol #: 277
C 1666 L. Gerick >Vol #: 277
C 1667 Women's Institute >Vol #: 277
C 1668 Feminist Women's Health Center >Vol #: 277
C 1669 J. Taylor >Vol #: 277
C 1670 W. Kray >Vol #: 277
C 1671 J. Backer,FNP,MSN >Vol #: 277
C 1672 Univeristy of Oklahoma >Vol #: 277
C 1673 W. Davidson, MSN,CNP >Vol #: 277
C 1674 J. Leopold >Vol #: 277
C 1675 Illegible >Vol #: 277
C 1676 M. Hofer >Vol #: 277
C 1677 B. Laris >Vol #: 277
C 1678 M. Gibbons-Arhelger >Vol #: 277
C 1679 S. Dickson >Vol #: 277
C 1680 L. Folda >Vol #: 277
C 1681 K. Hughes >Vol #: 277
C 1682 J. Knaster >Vol #: 277
C 1683 D. Parker,FNP,MSN >Vol #: 277
C 1684 C. Bensen,RN,ARNP >Vol #: 277
C 1685 A. Bazzano, MD >Vol #: 277
C 1686 E. Smith,CNM,NP,MS,RN >Vol #: 277
C 1687 T. Piskator >Vol #: 277
C 1688 W. Bernstein and signatures >Vol #: 277
C 1689 J. Behling >Vol #: 277
C 1690 J. Kelly >Vol #: 277
C 1691 J. Potempa >Vol #: 277
C 1692 Mr and Mrs L. Banks >Vol #: 277
C 1693 M and B Sauber >Vol #: 277
C 1694 V. Echols >Vol #: 277
C 1695 R. Harrison >Vol #: 277
C 1696 S. Hopkins >Vol #: 277
C 1697 K. Givens >Vol #: 277
C 1698 K. Freeman >Vol #: 277
C 1699 D. Coffin >Vol #: 277
C 1700 L. Peltz >Vol #: 277
C 1701 J. Staples,CRNP,MSN >Vol #: 277
C 1702 I. Schwartz >Vol #: 277
C 1703 D. Diers >Vol #: 277
C 1704 Women's Group >Vol #: 277
C 1705 West Virginia University School of Medicine >Vol #: 277
C 1706 D. Salvador >Vol #: 277
C 1707 R. Willis >Vol #: 277
C 1708 N. Hymes, MD >Vol #: 277
C 1709 R. Rutan >Vol #: 277
C 1710 M. Jones >Vol #: 277
C 1711 Illegible >Vol #: 277
C 1712 Illegible >Vol #: 277
C 1713 Illegible >Vol #: 277
C 1714 B. Williams >Vol #: 277
C 1715 Dr. R Glidewill >Vol #: 277
C 1716 L. Chamberlain, D.O. >Vol #: 277
C 1717 V. Miles >Vol #: 277
EC 797 Mrs. Delores Dautremont >Vol #: 163
EC 798 Miss. Deidre Allen >Vol #: 163
EC 799 Dr. Jennifer Wallander >Vol #: 163
EC 800 Midwest Health Center for Women >Vol #: 163
EC 801 Osseo Parents for Straight Talk About Sex >Vol #: 163
EMC 7257 C. Williams >Vol #: 237
EMC 7258 T. Dreher >Vol #: 237
EMC 7259 K. Giss >Vol #: 237
EMC 7260 J. T. Raymond >Vol #: 237
EMC 7261 S. MacLeod >Vol #: 237
EMC 7262 A. R. Ward >Vol #: 237
EMC 7263 A. M. Cohen >Vol #: 237
EMC 7264 E. R. >Vol #: 237
EMC 7265 C. Huerta >Vol #: 237
EMC 7266 A. Bernstein >Vol #: 237
EMC 7267 K. Robinson >Vol #: 237
EMC 7268 B. J. Giss >Vol #: 237
EMC 7269 E. Yu >Vol #: 237
EMC 7270 D. Hsieh >Vol #: 237
EMC 7271 D. Wingle >Vol #: 237
EMC 7272 T. Carreon >Vol #: 237
EMC 7273 L. Roesnthal >Vol #: 237
EMC 7274 K. Harkins >Vol #: 237
EMC 7275 T. Deaton >Vol #: 237
EMC 7276 C. Turner >Vol #: 237
EMC 7277 J. Vanover >Vol #: 237
EMC 7278 L. D. Hartsfield >Vol #: 237
EMC 7279 M. E. Wieland >Vol #: 237
EMC 7280 L. Rubinstein >Vol #: 237
EMC 7281 R. Mercury >Vol #: 237
EMC 7282 L. D. Jameson >Vol #: 237
EMC 7283 E. Durkee >Vol #: 237
EMC 7284 J. Getting >Vol #: 237
EMC 7285 A. Pancella >Vol #: 237
EMC 7286 B. Comstock >Vol #: 237
EMC 7287 A. Gevry >Vol #: 237
EMC 7288 A. Sullam >Vol #: 237
EMC 7289 C. Hensey >Vol #: 237
EMC 7290 A. S. Conrad >Vol #: 237
EMC 7291 T. Raymond >Vol #: 237
EMC 7292 B. Johnson >Vol #: 237
EMC 7293 M. Hughes >Vol #: 237
EMC 7294 A. Fisher >Vol #: 237
EMC 7295 J. L. Staples >Vol #: 237
EMC 7296 S. Harris >Vol #: 237
EMC 7297 A. Sullivan >Vol #: 237
EMC 7298 B. heney. R. PH. >Vol #: 237
EMC 7299 R. H. Escobales JR. , PH.D. >Vol #: 237
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
EC 2 SCHWARZ PHARMA AG >Vol #: 1
2004N-0221 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
EC 5 Mr. Gary Ray >Vol #: 1
EC 6 Iowa Department for the Blind >Vol #: 1
EC 7 National Federation of the Blind >Vol #: 1
EC 8 Mr. Joe Tolve >Vol #: 1
EC 9 National Federation of the Blind >Vol #: 1
EC 10 National federation of the Blind >Vol #: 1
EC 11 Ms. Julie Crane >Vol #: 1
2004Q-0180 Qualified Health Claim (QHC): Lutein and Eye Diseases
EC 3 Delaware Ophthalmology Consultants >Vol #: 5
EC 4 Dr. Rodney Horton >Vol #: 5
EC 5 Moran Eye Center, University of Utah >Vol #: 5
EC 6 H. Reisman Corporation >Vol #: 5

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