[Federal Register Volume 68, Number 204 (Wednesday, October 22, 2003)]
[Proposed Rules]
[Pages 60302-60304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 334

[Docket No. 1978N-036L]
RIN 0910-AA01


Laxative Drug Products for Over-the-Counter Human Use; Reopening 
of the Administrative Record

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule; reopening of the administrative record.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
January 20, 2004, the administrative record for the rulemaking for 
over-the-counter (OTC) laxative drug products to accept comments and 
data concerning these drug products that have been filed with FDA's 
Division of Dockets Management, because the administrative record 
officially closed at various times during the course of this 
rulemaking. The administrative record will remain open until January 
20, 2004, to allow for public comment on the comments and data being 
accepted into the rulemaking at this time. This action is part of FDA's 
ongoing review of OTC drug products.

DATES:  Submit written or electronic comments and data by January 20, 
2004.

ADDRESSES:  Submit written comments and data to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:  Mary S. Robinson, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has, on numerous occasions, received new data and information 
bearing on OTC drug panel reports and proposed monographs after the 
closing of the administrative record in a rulemaking proceeding. Under 
Sec.  330.10(a)(7)(iii) (21 CFR 330.10(a)(7)(iii)), new data and 
information may be submitted within 12 months after publication of a 
tentative final monograph (TFM). Within 60 days after this 12-month 
period ends, comments on the new data and information may be submitted 
(see Sec.  330.10(a)(7)(iv)). Under Sec.  330.10(a)(10)(i), the 
administrative record closes at the end of this 60-day period.
    FDA published a TFM on laxative drug products for OTC human use on 
January 15, 1985 (50 FR 2124). On a number of occasions since the TFM 
was published, FDA reopened the administrative record for this 
rulemaking for various reasons. (See table 1 of this document for 
reopening dates and reasons.)

[[Page 60303]]



    Table 1.--Chronology of the OTC Laxative Drug Products Rulemaking
                              Publications
------------------------------------------------------------------------
   Federal Register date and cite                  Document
------------------------------------------------------------------------
January 15, 1985 (50 FR 2124)        Proposed Rule (TFM) to Establish a
                                      Monograph for OTC Laxative Drug
                                      Products
------------------------------------------------------------------------
October 1, 1986 (51 FR 35136)        TFM Amendment to Modify the
                                      Directions for Use and Dosages of
                                      OTC Bulk-Forming Laxatives
------------------------------------------------------------------------
June 2, 1992 (57 FR 23174)           Notice to Reopen the Administrative
                                      Record to Accept Data and
                                      Information on Stimulant Laxative
                                      Active Ingredients Derived from
                                      Senna and Data on the Combination
                                      of Psyllium and Bran Active
                                      Ingredient
------------------------------------------------------------------------
September 2, 1993 (58 FR 46589)      TFM Amendment to Include Docusate
                                      Salts, i.e., Docusate Calcium,
                                      Docusate Potassium, and Docusate
                                      Sodium, as Generally Recognized as
                                      Safe and Effective (GRASE) and Not
                                      Misbranded
------------------------------------------------------------------------
March 31, 1994 (59 FR 15139)         TFM Amendment to Limit the OTC Drug
                                      Container Size for Sodium
                                      Phosphates Oral Solution to Not
                                      Greater Than 90 Milliliters (ml)
                                      (3 ounces (oz)) and to Add Warning
------------------------------------------------------------------------
September 2, 1997 (62 FR 46223)      TFM Amendment to Reclassify the
                                      Stimulant Laxatives Danthron and
                                      Phenolphthalein from Category I
                                      (GRASE and Not Misbranded) to
                                      Category II (Not GRASE or
                                      Misbranded)
------------------------------------------------------------------------
May 21, 1998 (63 FR 27886)           TFM Amendment to Include Additional
                                      General and Professional Labeling
                                      for Oral and Rectal Sodium
                                      Phosphates Drug Products
------------------------------------------------------------------------
June 19, 1998 (63 FR 33592)          TFM Amendment to Reclassify the
                                      Stimulant Laxative Ingredients
                                      Aloe, Bisacodyl, Cascara Sagrada,
                                      and Senna Preparations from
                                      Proposed Category I to Category
                                      III (More Data Needed)
------------------------------------------------------------------------
December 9, 1998 (63 FR 67817)       Notice of Withdrawal of Proposed
                                      TFM Amendment for Additional
                                      Professional Labeling for Oral and
                                      Rectal Sodium Phosphates Drug
                                      Products with Intent to Repropose
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August 5, 2003 (68 FR 46133)         TFM Amendment to Reclassify the
                                      Bulk-Forming Laxative Psyllium
                                      Ingredients (Psyllium (Hemi-
                                      Cellulose), Psyllium Hydrophilic
                                      Mucilloid, Psyllium Seed, Psyllium
                                      Seed (Blond), Psyllium Seed Husks,
                                      Plantago Ovata Husks, and Plantago
                                      Seed)) in a Granular Dosage Form
                                      From Proposed Category I to
                                      Category II
------------------------------------------------------------------------

    Under Sec.  330.10(a)(7)(v), new data and information submitted 
after the administrative record closed, before the establishment of a 
final monograph (FM), are considered a petition to amend the monograph 
and are to be considered only after a FM has been published unless FDA 
finds that good cause has been shown that warrants earlier 
consideration. Further, under Sec.  330.10(a)(10)(ii), FDA shall make 
all decisions and issue all orders under Sec.  330.10 in the FM solely 
on the basis of the administrative record and shall not consider data 
or information not included as part of the administrative record.
    FDA has received new data and information submitted to the 
rulemaking for OTC laxative drug products after the administrative 
record closed on the various dates after the TFM amendments listed in 
table 1 of this document (excluding August 5, 2003, for which the 
administrative record remains open until November 3, 2003). In some 
cases, interested persons submitted a petition to reopen the record. In 
other cases, they submitted new data and information to the Division of 
Dockets Management as comments on the amended TFM. A number of the 
petitions and comments submitted to the amended TFM contain new data 
and information.
    FDA has previously answered a number of these petitions (Refs. 1 
through 7), and its response has been a final action on the petition. 
Thus, the current reopening of the administrative record does not 
include further comment on or consideration of the issues in these 
petitions. A summary of these petitions is included in table 2 of this 
document.

                   Table 2.--Summary of Citizen Petitions on Which FDA Has Taken Final Action
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        Docket code               Date of letter                  Action                       Subject
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PDN14                       June 4, 1996                Denial of CP18              Magnesium Citrate in Other
                                                                                     Ddosage Forms
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PDN4                        August 22, 1997             Denial of CP14              Two 45 Milliliter Doses of
                                                                                     Sodium Phosphates Oral
                                                                                     Solution 10 to 12 Hours
                                                                                     Apart as a Bowel Cleansing
                                                                                     System
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[[Page 60304]]

 
PDN5                        August 22, 1997             Denial of CP16              Time to Action Statement for
                                                                                     Enema Dosage of Glycerin
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PDN6                        September 5, 1997           Denial of CP13              Sorbitol in an Oral Dosage
                                                                                     Form
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ANS4                        October 15, 1997            Denial of CP17              1,200 Milligram Single Dose
                                                                                     of Magnesium Hydroxide
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PDN7                        January 7, 1998             Denial of CP23              Magnesium Citrate Powder for
                                                                                     Oral Solution
----------------------------------------------------------------------------------------------------------------
PDN11                       July 2, 2001                Denial of CP20 and          Bowel Cleansing System Using
                                                         response to C205            a Large Volume Tap Water
                                                                                     Enema as the Final
                                                                                     Cleansing Step
----------------------------------------------------------------------------------------------------------------

    Because the data in other petitions and comments are relevant to 
the final classification of conditions for marketing OTC laxative drug 
products under the FM, FDA has determined that good cause exists to 
consider these new data and information in developing the FM for these 
products. By this document, FDA announces that it is treating all of 
these submissions (excluding the petitions listed in table 2 of this 
document), received after the administrative record closed at various 
times, as petitions to reopen the administrative record, and is 
granting the petitions by allowing the new data and information 
contained therein to be included in the administrative record for the 
rulemaking for OTC laxative drug products.

II. Reopening of the Administrative Record

    Accordingly, FDA is reopening the administrative record for this 
rulemaking to provide the following actions: (1) Accept data and 
information previously submitted to the Division of Dockets Management 
after the administrative record closed following publication of the TFM 
and the various reopenings of the record listed in table 1 of this 
document and (2) provide interested persons an opportunity to submit 
comments on these data and information before the closing of the 
record.
    FDA is providing a period of 90 days for these comments and new 
data and information to be submitted. Interested persons have already 
had an opportunity to submit objections or requests for an oral hearing 
on the amended TFM. Thus, this reopening of the administrative record 
to submit comments and information does not include submission of 
objections and requests for an oral hearing. Any comments at this time 
should specifically identify the data and information on which the 
comments are being provided. In addition, only new information related 
to the submissions being included in the administrative record at this 
time should be submitted.
    Any data and information previously submitted to this rulemaking 
need not be resubmitted. In establishing an FM, FDA will consider only 
comments, data, and information submitted prior to the closing of the 
administrative record following this current reopening.
    On August 5, 2003, FDA reopened the administrative record to 
reclassify the bulk-forming laxative psyllium ingredients (psyllium 
(hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, 
psyllium seed (blond), psyllium seed husks, plantago ovata husks, and 
plantago seed)) in a granular dosage form from proposed Category I to 
Category II. Comments and information in response to that reopening of 
the administrative record should be submitted by November 3, 2003.

III. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or three paper copies of 
any mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) under Docket No. 1978N-036L and may be seen 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment No. PDN14.
    2. Comment No. PDN4.
    3. Comment No. PDN5.
    4. Comment No. PDN6.
    5. Comment No. ANS4.
    6. Comment No. PDN7.
    7. Comment No. PDN11.

    Dated: October 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26570 Filed 10-21-03; 8:45 am]
BILLING CODE 4160-01-S