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FINAL RULES - FEDERAL REGISTER NOTICES - 2002

AS OF 8/21/2002

**Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305,
Rockville, MD, 20852**

**General number: 301-827-6860**

**Fax 301-827-6870**

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**Get this listing automatically every month by subscribing to FDA-RULES
[here](http://www.fda.gov/ohrms/dockets/FDAMAIL/DMBemaillist.htm)**

**See other selected documents with upcoming comment closing dates
[here](http://www.fda.gov/ohrms/dockets/DOCKETSCLOSE/Commentsdue.htm)**

**See proposed rules in 2002 [here](../nprrules.htm)**

**FINAL RULES**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 15, 2002): Docket No. 02N-0251, OC 200250.  Presiding Officers
at Regulatory Hearings.  Pages  53305\--53306 \[FR Doc. 02-20701\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/081502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/081502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0251-n000002.pdf)\]
Comments by [October 29, 2002]{.underline} Effective [December 30,
2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 7, 2002): NADA 8--804;95-143, CVM 200115.  New Animal Drugs for
Use in Animal Feeds; Oxytetracycline.  Pages  51081-51082 \[FR Doc.
02-19905\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702c.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/8-804-nfr0001.pdf)\]
Effective [August 7, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/8-804-fois0001.pdf) NADA
8-804\
[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/95-143-fois001.pdf) NADA
95-143**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 7, 2002): ANADA 200--168, CVM 200234.  New Animal Drugs; Change
of Sponsor.  Page  51080 \[FR Doc. 02-19861\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702c.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200168_nfr00001.pdf)\]
Effective [August 7, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 7, 2002): ANADA 00--026, CVM 2001103.  Oral Dosage Form New
Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder.  Pages 
51080-81081 \[FR Doc. 02-19864\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200026._nfr00001.pdf)\]
Effective [August 7, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200026_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 7, 2002): NADA 141--200, CVM 200250.  New Animal Drugs; Change
of Sponsor.  Pages  51079-51080 \[FR Doc. 02-19862\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702e.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada141200_nfr00001.pdf)\]
Effective [August 7, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 7, 2002): CVM 200235.  New Animal Drugs; Change of Sponsor\'s
Name.  Page  51079 \[FR Doc. 02-19906\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702d.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv0235-nfr0001.pdf)\]
Effective [August 7, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 6, 2002): CVM 200219.  New Animal Drugs; Change of Sponsor\'s
Address.  Page  50802 \[FR Doc. 02-19767\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv0219_nfr0001.pdf)\]
Effective [August 6, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(August 5, 2002): ANADA 200--327, CVM 20021.  Oral Dosage Form New
Animal Drugs; Ivermectin Liquid.  Pages  50596\--50597 \[FR Doc.
02-19729\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/080502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/080502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada20-327_nfr0001.pdf)\]
Effective [August 5, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-327_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 31, 2002): Docket No. 00C-0929, CFSAN 200226.  Listing of Color
Additives Exempt From Certification; Sodium Copper Chlorophyllin;
Confirmation of Effective Date.  Pages  49567---49568 \[FR Doc.
02-19300\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/073102b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/073102b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00c0929_ncd0001.pdf)\]
Effective [June 20, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 25, 2002): NADA 141--195, CVM 2001114.  New Animal Drugs for Use
in Animal Feeds; Diclazuril and Bambermycins.  Pages  48549\--48550 \[FR
Doc. 02-18877\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/072502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/072502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-495_nfr00001.pdf)\]
Effective [July 25, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-495_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 24, 2002): Docket No. 97N-0023, CDER 1999119.  Use of
Ozone-Depleting Substances; Essential-Use Determinations.  Pages 
48370---48385 \[FR Doc. 02-18610\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/072402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/072402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/97n-0023-nfr0001.pdf)\]
Effective [January 20, 2003]{.underline} Applicability Date [August 25,
2003]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 22, 2002): NADA 140-863, CVM 200123.  New Animal Drugs for Use in
Animal Feeds; Ractopamine.  Pages  47691-47692 \[FR Doc. 02-18365\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/072202b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/072202b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/140-863-nfr0001.pdf)\]
Effective [July 22, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/140-863-fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 22, 2002): NADA 124-309;125-476, CVM 200184.  New Animal Drugs for
Use in Animal Feeds; Melengestrol.  Pages  47687-47691 \[FR Doc.
02-18367 \] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/072202a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/072202a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/NADAS124-309-125-476-nfr0001.pdf)\]
Effective [July 22, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/NADAS124-309-125-476-fois001.pdf)
NADA 124-309, 125-476\
[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/fois-138-870.pdf.url)
NADA 138-870, 138-792\
[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/fois-139-192.pdf) NADA
139-192, 138-995**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 19, 2002): ANADA 200--232, CVM 2001100.  Implantation or
Injectable Dosage Form New Animal Drugs; Oxytetracycline.  Pages 
47450\--47451 \[FR Doc. 02-18178\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071902b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-232-n000001.pdf)\]
Effective [July 19, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-232-fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 19, 2002): NADA 121--473, CVM 20022.  Oral Dosage Form New Animal
Drugs; Fenbendazole Granules.  Page  47450 \[FR Doc. 02-18177\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071902a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv022-n000001.pdf)\]
Effective [July 19, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-121-473-fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 18, 2002): NADA 141-194, CVM 2001113.  New Animal Drugs for Use in
Animal Feeds; Diclazuril and Bacitracin Methylene Disalicylate.  Pages 
47257-47258 \[FR Doc. 02-18119\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071802a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071802a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-194_nfr0001.pdf)\]**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-194_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 17, 2002): Docket No. 02P-0294, CDRH 1999101.  Medical Devices;
Reclassification of Polymethylmethacrylate (PMMA) Bone Cement.  Pages 
46852\--46855 \[FR Doc. 02-18036\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702c.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702c.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/02p-0294_nfr00001.pdf)\]
Effective [August 16, 2002]{.underline}**

**[The
Guidance](http://www.fda.gov/OHRMS/DOCKETS/98fr/02p-0294-gdl0001-vol1.DOC)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 17, 2002): Docket No. 00N-1457, CDRH 200143.  CDRH200143, Docket
No., Medical Devices; Apnea Monitor; Special Controls.  Pages 
46851\--46852 \[FR Doc. 02-17957\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1457_nfr0001.pdf)\]
Effective [October 15, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 17, 2002): Docket No. 98F-0196, CVM 200224.  Food Additives
Permitted in Feed and Drinking Water of Animals; Selenium Yeast.  Pages 
46850\--46851 \[FR Doc. 02-17959\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/98f-0196_nfr0002.pdf)\]
Effective [July 17, 2002]{.underline} Objections and hearing requests by
[September 16, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 11, 2002): CVM 2001102.  Implantation or Injectable Dosage Form
New Animal Drugs; Ceftiofur Hydrochloride.  Pages  45901-45902 \[FR Doc.
02-17404\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nfr0003-cv01102.pdf)\]
Effective [July 11, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/fois1-140-890.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 11, 2002): CVM 200233.  New Animal Drugs; Change of Sponsor\'s
Address.  Pages  45900-45901 \[FR Doc. 02-17405\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nfr0001-cv0233.pdf)\]
Effective [July 11, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 11, 2002): OC 2002146.  Advisory Committee: Change of Name and
Function; Technical Amendment.  Page  45900 \[FR Doc. 02-17401\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102c.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/071102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nfr00001-oc02146.pdf)\]
Effective [July 11, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 9, 2002): Docket Nos. 98F-0052 , 99F-0187, CFSAN 20025.  Food
Additives Permitted for Direct Addition to Food for Human Consumption;
Neotame.  Pages  45300-45310 \[FR Doc. 02-17202\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/070802a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/070802a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cf025.pdf)\] Effective
[July 9, 2002]{.underline} Written objections and hearing requests by
[August 9, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(July 5, 2002): CVM 2001106.  Animal drugs, feeds, and related
products:Lincomycin GPO correction \[NO FDA PRE-PUB\].  Page  44931 \[FR
Doc. C2-13164\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/070502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/070502a.pdf)\] \[NO
PRE-PUB\]**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 27, 2002): NADA 48-761, CVM 200181.  New Animal Drugs for Use in
Animal Feeds; Chlortetracycline.  Pages  43248\--43252 \[FR Doc.
02-16161\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada48-761_nfr0001.pdf)\]
Effective [June 27, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada48-761_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 27, 2002): NADA 101-497, CVM 200210.  New Animal Drugs; Change of
Sponsor \[21 CFR Parts 510 & 520\].  Pages  43247\--43248 \[FR Doc.
02-16050\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062702b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062702b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada101-497_nfr0001.pdf)\]
Effective [June 27, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 26, 2002): CVM 200211.  New Animal Drugs; Change of Sponsor \[21
CFR Part 510\].  Page  42997 \[FR Doc. 02-16051\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv0211_nfr000001.pdf)\]
Effective [June 26, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 26, 2002): Docket Nos. 76N-0080 , 00N-1610, CDER 2000164.  Digoxin
Products for Oral Use; Revocation of Conditions for Marketing.  Pages 
42992\--42997 \[FR Doc. 02-16108\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062602b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062602b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/76n-0080_nfr0002.pdf)\]
Effective [July 26, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 25, 2002): CVM 200226.  New Animal Drugs; Change of Sponsor\'s
Name and Address.  Page  42717 \[FR Doc. 02-15900\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv0226_nfr00001.pdf)\]
Effective on [June 25, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 25, 2002): Docket No. 89F-0452, CFSAN 2000138.  Secondary Direct
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Materials Used as Fixing Agents in the Immobilization of
Enzyme Preparations.  Pages  42714\--42717 \[FR Doc. 02-15901\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062502b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062502b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/89f-0452_nfr0001.pdf)\]
Effective on [June 25, 2002]{.underline} Written objections and hearing
requests by [July 25, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 20, 2002): NADA 141-200, CVM 200217.  Certain Other Dosage Form
New Animal Drugs; Progesterone Intravaginal Inserts.  Pages 
41823\--41825 \[FR Doc. 02-15633\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062002a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062002a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-200_nfr00001.pdf)\]
Effective [June 20, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-200_fois.pdf)\
[Finding of No Significant
Impact](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-200_fnsi.pdf)\
[Environmental
Assessment](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-200_ea.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 20, 2002): Docket No. 78N-0038, CDOTC 200112.  CDER 01185
Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph;
Technical Amendment.  Pages  41821\--41823 \[FR Doc. 02-15632\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/062002b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/062002b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/78n-0038_nfr000001.pdf)\]
Effective [September 1, 2002]{.underline} Comments by [August 19,
2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 14, 2002): Docket No. 99N-0922, CDRH 200160.  Obstetric and
Gynocology Devices; Effective Date of Requirement for Premarket Approval
for Glans Sheath Devices.  Pages  40848\--40849 \[FR Doc. 02-15042\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/061402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/061402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/99n-0922-n000001-vol1.pdf)\]
Effective [June 14, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(June 6, 2002): Docket No. 00N-1367, CDRH 200129.  Postmarket
Surveillance.  Pages  38878---38892 \[FR Doc. 02-14100\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/060602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/060602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1367_nfr0001.pdf)\]
Effective on [July 8, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 31, 2002): Docket No. 98N-0237, CDER 20000100.  New Drug and
Biological Drug Products; Evidence Needed to Demonstrate Effectiveness
of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible. 
Pages  37988-37998 \[FR Doc. 02-13583\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0237-nfr0001-vol1.pdf)\]
Effective date [July 1, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 24, 2002): NADA 97-505, CVM 2001106.  New Animal Drugs for Use in
Animal Feeds; Lincomycin.  Pages  36512-36514 \[FR Doc. 02-13164\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/052402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/052402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/97-505-nfr0001.pdf)\]
Effective [May 24, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/97-505-fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 23, 2002): NADA 141-185, CVM 2001101.  New Animal Drugs for Use in
Animal Feeds; Decoquinate and Chlortetracycline.  Pages  36097---36098
\[FR Doc. 02-12873\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/052302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/052302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-185-nfr0001.pdf)\]
Effective [May 23, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-185-fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 21, 2002): Docket No. 99N-5556, CFSAN 2000124.  Food Additives:
Food Contact Substance Notification System.  Pages  35724---35731 \[FR
Doc. 02-12661\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/052102a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/052102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/99n-5556-nfr0001-vol1.pdf)\]
Effective on [June 20, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 20, 2002): Docket No. 00C-0929, CFSAN 200136.  Listing of Color
Additives Exempt From Certification; Sodium Copper Chlorophyllin. 
Pages  35429\--35431 \[FR Doc. 02-12544\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/052002a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/052002a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00c-0929-nfr0001-vol1.pdf)\]
Objections and hearing requests by [June 19, 2002]{.underline} Rule
effective [June 20, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 16, 2002): NADA 141-190, CVM 200183.  New Animal Drugs for Use in
Animal Feeds; Diclazuril.  Pages  34829---34831 \[FR Doc. 02-10963\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/051602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/051602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-190-nfr0001.pdf)\]
Effective on [May 16, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-190-fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 14, 2002): Docket No. 98N-0583, OC 200291.  Exports; Notification
and Recordkeeping Requirements; Stay of Effective Date.  Page  34387
\[FR Doc. 02-11935\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/051402b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/051402b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/98-0583_nfr0002.pdf)\]
Effective [May 14, 2002]{.underline} 21 CFR 1.101 is stayed until [June
19, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 14, 2002): ANADA 200-274, CVM 2001104.  Implantation or Injectable
Dosage Form New Animal Drugs; Lincomycin.  Pages  34387\--34388 \[FR
Doc. 02-11933\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/051402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/051402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-274_nfr0001.pdf)\]
Effective [May 14, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-274-fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 9, 2002): Docket No. 78N-036L, CDOTC 17.  Status of Certain
Additional Over-the-Counter Drug Category II and III Active Ingredients
concerning stimulant laxative ingredients aloe (including aloe extract
and aloe flower extract) and cascara sagrada (including casanthranol,
cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada
extract, and cascara sagrada fluidextract).  Pages  31125---31127 \[FR
Doc. 02-11510\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050902a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/78n-036L-nfr0004-vol107.pdf)\]
Effective [November 5, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 9, 2002): Docket No. 80N-0280, COTC 13.  Status of Certain
Additional Over-the-Counter Drug Category II and III Active Ingredients
addresses the ingredient octoxynol 9, considered in the rulemaking for
OTC vaginal contraceptive drug products.  Pages  31123---31125 \[FR Doc.
02-11511\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050902b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050902b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0002-vol12.pdf)\]
Effective [November 5, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 8, 2002): Docket Nos. 96P-0500, 91N-384H , CFSAN 20026.  Food
Labeling; Nutrient Content Claims, Definition of Sodium Levels for the
Term Healthy; Extension of Partial Stay.  Pages  30795---30796 \[FR Doc.
02-11378\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050802a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050802a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/91n-0384h_nsa0002.pdf)\]
Comments by [June 7, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 7, 2002): NADA 141-154, CVM 200178.  New Animal Drugs for Use in
Animal Feeds; Bacitracin Methylene Disalicylate and Robenidine
Hydrochloride.  Pages  30545---30546 \[FR Doc. 02-11207\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-154_nfr00001.pdf)\]
Effective [May 7, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-154_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 6, 2002): NADA 141-124, CVM 199928.  New Animal Drugs for Use in
Animal Feeds; Nicarbazin, Narasin, and Bacitracin Methylene
Disalicylate.  Pages  30326-30328 \[FR Doc. 02-10964\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-141-124-nfr0001.pdf)\]
Effective on [May 6, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-141-124-fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 2, 2002): CVM 20025.  Oral Dosage Form New Animal Drugs; Change of
Sponsor.  Page  21996 \[FR Doc. 02-10793\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050202a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050202a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-270-nfr0002.pdf)\]
Effective [May 2, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(May 2, 2002): CVM 200136.  New Animal Drugs for Use in Animal Feeds;
Tilmicosin.  Pages  21996---21997 \[FR Doc. 02-10792\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/050202b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/050202a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-064-nfr1.pdf)\]
Effective [May 2, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada141-064-fois1.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 30, 2002): Docket No. 99P-1864, CDRH 200172.  Orthopedic Devices:
Reclassification of the Hip Joint Metal/Polymer Constrained Cemented or
Uncemented Prosthesis.  Pages  21171---21173 \[FR Doc. 02-10509\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/043002b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/043002a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/99p-1864-nfr0001-vol3.pdf)\]
Effective on [May 30, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 30, 2002): NADA 39-077, CVM 2001107.  New Animal Drugs; Change of
Sponsor \[21 CFR Part 558\].  Page  21171 \[FR Doc. 02-10511\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/043002a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/043002a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-39-077-nfr0001.pdf)\]
Effective on [April 30, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 29, 2002): Docket No. 97P-0210, CDRH 200168.  Medical Devices;
Ear, Nose and Throat Devices; Reclassification of the Endolymphatic
Shunt Tube With Valve.  Pages  20893---20894 \[FR Doc. 02-10426\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/042902a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/042902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/97p-0210_nfr0001_vol2.pdf)\]
Effective on [May 29, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 15, 2002): NADA 34-478,ANADA 200-293, CVM 200192.  Implantation
or Injectable Dosage Form New Animal Drugs; Furosemide.  Page  18086
\[FR Doc. 02-09014\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/041502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/041502b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada-200-293_nfr0001.pdf)\]
Effective [April 15, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada-200-293_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 15, 2002): NADA 140-872, CVM 2001105.  Implantation or Injectable
Dosage Form New Animal Drugs; Sometribove Zinc Suspension.  Page  18085
\[FR Doc. 02-09015\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/041502b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/041502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-140-872_nfl0001.pdf)\]
Effective [April 15, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada-140-872_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 10, 2002): NADA 111-636, CVM 200150.  Oral Dosage Form New Animal
Drugs; Lincomycin Hydrochloride Soluble Powder.  Page  17284 \[FR Doc.
02-08570\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/041002b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/041002b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada111-636_nfl0001_vol1.pdf)\]
Effective [April 10, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada111-636_fois001_vol1.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 10, 2002): ANADA 200-257, CVM 200146.  Implantation or Injectable
Dosage Form New Animal Drugs; Ketamine Hydrochloride.  Pages 
17282-17284 \[FR Doc. 02-08569\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/041002a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/041002a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-257_nfr0001_vol1.pdf)\]
Effective [April 10, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-257_fois001_vol1.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 5, 2002): Docket Nos. 98N--0337, 96N-0420, 95N-0259, 90P-0201,
CDOTC 200117.  Over-the-Counter Human Drugs; Labeling Requirements;
Partial Delay of Compliance Dates.  Pages  16304-16308 \[FR Doc.
02-08193\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/040502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/040502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0337_nfr0003.pdf)\]
Effective [May 6, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(April 3, 2002): Docket No. 01F-0233, CFSAN 200166.  Secondary Direct
Food Additives Permitted in Food for Human Consumption.  Pages 
15719---15720 \[FR Doc. 02-07969\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/040302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/040302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/01f-0233_nfr0001.pdf)\]
Effective [April 3, 2002]{.underline} Written objections and hearing
requests by [May 3, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 26, 2002): CVM 2001109.  New Animal Drugs; Change of Sponsor\'s
Name and Address.  Pages  13717-13718 \[FR Doc. 02-07147\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/032602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/032602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/cv01109_nfr0001.pdf)\]
Effective on [March 26, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 26, 2002): Docket No. 02N-0086, OC 200265.  Public Information;
Cross Reference to Other Regulations; Technical Amendment.  Page  13717
\[FR Doc. 02-07180\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/032602b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/032602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/02n_0086_nfr0001.pdf)\]
Comments by [March 26, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 19, 2002): ANADA 200-123, CVM 2000135.  Implantation or
Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection. 
Pages  12470-12471 \[FR Doc. 02-06492\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/031902a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/031902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-123_nfr0002.pdf)\]
Effective on [March 19, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-123_fois002.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 15, 2002): Docket No. 96P-0460, OC 200256.  Topical Antifungal
Drug Products for Over-the-Counter Human Use; Amendment of Final
Monograph ; Correction.  Page  11571 \[FR Doc. 02-16180\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/031502a.html)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/031502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/96p-0460_nfr0002.pdf)\]**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 13, 2002): NADA 138-412,ANADA 200-270, CVM 200180.  Oral Dosage
Form New Animal Drugs; Ivermectin Tablets.  Pages  11229-11230 \[FR Doc.
02-05060\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/031302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/031302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-270_nfr0001.pdf)\]
Effective on [March 13, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-270_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 4, 2002): OC 20029.  Change in the Removal of the Office of
Management and Budget (OMB) Control Numbers; Technical Amendment. 
Pages  9584-9588 \[FR Doc. 02-04962\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/030402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/030402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nfr0001.pdf)\]**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(March 1, 2002): CVM 200177.  Implantation or Injectable Dosage Form New
Animal Drugs; Flunixin Meglumine Solution.  Page  9400 \[FR Doc.
02-04891\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/030102a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/030102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-124_nfr0001.pdf)\]
Effective on [March 1, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-124_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 27, 2002): ANADA 200-301, CVM 200171.  Ophthalmic and Topical
Dosage Form New Animal Drugs; Chlorhexidine Ointment.  Page  8860 \[FR
Doc. 02-04595\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/022702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/022702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-301_nfr0001.pdf)\]
Effective [February 27, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/anada200-301_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 19, 2002): NADA 139-472, CVM 200128.  New Animal Drugs for Use
in Animal Feeds; Tiamulin.  Pages  7268-7269 \[FR Doc. 02-03831\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021902a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021902a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/139-472_nfr0001.pdf)\]
Effective [February 19, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/139-472_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 15, 2002): NADA 141--180, CVM 200151.  Certain Other Dosage
Form New Animal Drugs; Albuterol.  Page  7072 \[FR Doc. 02-03738\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021502a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021502a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-180_nfr0001.pdf)\]**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-180_fois0001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 14, 2002): NADA 141-085, CVM 199932.  New Animal Drugs for Use
in Animal Feeds; Bacitracin Methylene Disalicylate and Zoalene.  Pages 
6867-6869 \[FR Doc. 02-03614\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-085_nfr0001.pdf)\]
Effective on [February 14, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-085_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 14, 2002): NADA 141-192, CVM 200173.  Implantation or
Injectable Dosage Form New Animal Drugs; Zeranol.  Pages  6866---6867
\[FR Doc. 02-03681\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402d.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402c.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-192_nfr0001.pdf)\]
Effective on [February 14, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-192_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 14, 2002): NADA 141-063, CVM 200187.  Implantation or
Injectable Dosage Form New Animal Drugs; Florfenicol.  Page  6866 \[FR
Doc. 02-03680\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402c.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402c.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-063_nfr0001.pdf)\]
Effective on [February 14, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 14, 2002): NADA 141-111, CVM 200191.  Oral Dosage Form New
Animal Drugs; Carprofen.  Pages  6865---6866 \[FR Doc. 02-03682\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021402b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-111_nfr0002.pdf)\]
Effective on [February 14, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/141-111_fois002.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 13, 2002): Docket No. 92N--0297, CDER 2001150.  Prescription
Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;
Policies, Requirements, and Administrative Procedures; Delay of
Effective Date.  Pages  6645\--6647 \[FR Doc. 02-03282 \] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/021302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/021302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/92n-0297_nfr0002.pdf)\]
Effective on [April 1, 2003]{.underline} Comments by [April 15,
2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 8, 2002): Docket No. 00N-1034, CDRH 200064.  Medical Devices;
Device Tracking.  Pages  5943---5952 \[FR Doc. 02-03076\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020802b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020802b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1034__nfr0001.pdf)\]
Effective [May 9, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 8, 2002): Docket No. 99N-4063, CDOTC 200113.  Topical
Antifungal Drug Products for Over-the-Counter Human Use; Amendment of
Final Monograph.  Pages  5942\--5943 \[FR Doc. 02-03079\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020802a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020802a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/99n-4063_nfr0001.pdf)\]
Effective on [March 11, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 7, 2002): NADA 140-992, CVM 200186.  Implantation or
Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol. 
Page  5724 \[FR Doc. 02-02949\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020702a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020702a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada_140-992_nfr0001.pdf)\]
Effective [February 7, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/nada_140-992_fois001.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 6, 2002): Docket No. 01N-0499, CVM 199865.  Topical
Nitrofurans; Extralabel Animal Drug Use; Order of Prohibition.  Pages 
5470---5471 \[FR Doc. 02-02751\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602b.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602b.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/01n_0499_nfr0001.pdf)\]
Comments by [April 8, 2002]{.underline} Effective [May 7,
2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 6, 2002): ANADA 200-066, CVM 200142.  Oral Dosage Form New
Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder; Technical
Amendment.  Page  5469 \[FR Doc. 02-02589\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-066_nfr0003.pdf)\]
Effective [February 6, 2002]{.underline}**

**[Freedom of Information
Summary](http://www.fda.gov/OHRMS/DOCKETS/98fr/200-066_fois.pdf)**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 6, 2002): Docket No. 99N-4578, CDRH 200065.  State
Certification of Mammography Facilities.  Pages  5446---5469 \[FR Doc.
02-02750\]  \[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602c.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020602c.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/99n-4578_nfr0001.pdf)\]
Comments by [March 8, 2002]{.underline} Effective [May 7,
2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(February 1, 2002): Docket No. 00N-0086, CDER 200074.  Amendment of
Regulations Regarding Certain Label Statements on Prescription Drugs. 
Pages  4904---4907 \[FR Doc. 02-02548\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/020102a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/020102a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-0086_nfr0001_vol1.pdf)\]
Effective on [April 2, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(January 24, 2002): Docket No. 01P-0304, CDRH 200151.  Medical Devices;
Gastroenterology-Urology Devices; Classification of the Ingestible
Telemetric Gastrointestinal Capsule Imaging System.  Pages  3431---3433
\[FR Doc. 02-01722\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/012402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/012402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/01p-0304_nfr0001_vol1.pdf)\]
Effective [February 25, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(January 23, 2002): Docket No. 96N-0277, CDOTC 20003.  Additional
Criteria and Procedures for Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and Effective and Not Misbranded.  Pages 
3060---3076 \[FR Doc. 02-01457\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/012302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/012302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/96n-0277_nfr0001_vol1.pdf)\]
Effective [February 22, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(January 14, 2002): Docket No. 95P-0315, CDRH 200148.  Hematology and
Pathology Devices; Reclassification of the Automated Differential Cell
Counter.  Pages  1606---1607 \[FR Doc. 00792\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/011402a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/011402a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/95p-0315_nfr0001.pdf)\]
Effective on [February 13, 2002]{.underline}**

\<!DOCTYPE HTML PUBLIC \"-//W3C//DTD HTML 3.2 Final//EN\"\>**Vol. 67
(January 3, 2002): Docket No. 00F-1482, CFSAN 200157.  Secondary Direct
Food Additives Permitted in Food for Human Consumption; Correction. 
Page  271 \[FR Doc. 02-00044\] 
\[[TXT](http://www.fda.gov/OHRMS/DOCKETS/98fr/010302a.htm)\]
\[[PDF](http://www.fda.gov/OHRMS/DOCKETS/98fr/010302a.pdf)\]
\[[PRE-PUB](http://www.fda.gov/OHRMS/DOCKETS/98fr/00f-1482_nfr0002.pdf)\]**