[Federal Register Volume 68, Number 103 (Thursday, May 29, 2003)]
[Proposed Rules]
[Pages 32003-32004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 333

[Docket No. 75N-183H]
RIN 0910-AA01


Topical Antimicrobial Drug Products for Over-the-Counter Human 
Use; Health-Care Antiseptic Drug Products; 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 
August 27, 2003, the administrative record for the rulemaking for over-
the-counter (OTC) topical antimicrobial drug products to accept 
comments and data concerning OTC health-care antiseptic drug products 
that have been filed with the Dockets Management Branch, FDA, since the 
administrative record officially closed. The agency is also providing 
for the administrative record to remain open until August 27, 2003, to 
allow for public comment on the comments and data being accepted into 
the rulemaking. This action is part of FDA's ongoing review of OTC drug 
products.

DATES: Submit written comments and data or electronic comments by 
August 27, 2003.

ADDRESSES: Submit written comments and data to the Dockets Management 
Branch (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: Michelle M. Jackson, 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

[[Page 32004]]

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 an amended TFM on OTC topical antimicrobial health-
care antiseptic drug products for OTC human use on June 17, 1994 (59 FR 
31402). The administrative record for this TFM closed on August 17, 
1995. Under Sec.  330.10(a)(7)(v), new data and information submitted 
after August 17, 1995, prior to 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 the agency finds 
that good cause has been shown that warrants earlier consideration. 
Further, under Sec.  330.10(a)(10)(ii), the agency 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 
antimicrobial rulemaking after the administrative record closed on 
August 17, 1995. In some cases, interested persons submitted a petition 
to reopen the record. In other cases, they submitted new data and 
information to the Dockets Management Branch as comments on the amended 
TFM. A number of the petitions and comments submitted to the amended 
TFM contain new data on proposed nonmonograph (Category II and Category 
III) ingredients and on the proposed final formulation testing criteria 
for health-care antiseptic drug products.
    Because these data are relevant to the final classification of 
these ingredients and to the testing criteria to be established in 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, 
received after the administrative record closed, 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 topical antimicrobial 
health-care antiseptic drug products.
    In response to the TFM, the agency received three citizen petitions 
concerning ingredients that lacked marketing history for the requested 
use in the United States to be eligible for the OTC drug review (Refs. 
1, 2, and 3). The agency has developed a process by which drugs without 
any marketing experience in the United States could be eligible for 
consideration in the agency's OTC drug review. This process is 
described in 21 CFR 330.14. The petitioners were informed to use that 
process (Refs. 4, 5, and 6). Thus, these citizen petitions are not 
included as part of the reopening of the administrative record.

II. Reopening of the Administrative Record

    Accordingly, the agency is reopening the administrative record for 
this rulemaking to accept data and information previously submitted to 
the Dockets Management Branch into the administrative record and to 
provide interested persons an opportunity to submit comments on these 
data and information prior to the closing of the record.
    The agency 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 comments, objections, or requests 
for an oral hearing on the amended TFM. Therefore, any comments at this 
time should only address the data and information submitted to the 
administrative record after August 17, 1995, and 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, the agency 
will consider only comments, data, and information submitted prior to 
the closing of the administrative record following this current 
reopening.

III. Request for Comments

    Three copies of all written comments are to be submitted. 
Individuals submitting written comments or anyone submitting electronic 
comments may submit one 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 Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

IV. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) under Docket No. 75N-183H and may be 
see by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday.
    1. Comment No. CP1.
    2. Comment No. CP8.
    3. Comment No. CP13.
    4. Comment No. LET23.
    5. Comment No. LET24.
    6. Comment No. LET33.

    Dated: May 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13317 Filed 5-28-03; 8:45 am]
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