[Federal Register: October 22, 2003 (Volume 68, Number 204)]
[Proposed Rules]
[Page 60302-60304]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc03-20]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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Federal Register date and cite Document
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January 15, 1985 (50 FR 2124) Proposed Rule (TFM) to Establish a
Monograph for OTC Laxative Drug
Products
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October 1, 1986 (51 FR 35136) TFM Amendment to Modify the
Directions for Use and Dosages of
OTC Bulk-Forming Laxatives
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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
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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)
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May 21, 1998 (63 FR 27886) TFM Amendment to Include Additional
General and Professional Labeling
for Oral and Rectal Sodium
Phosphates Drug Products
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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)
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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
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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
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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