[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Proposed Rules]
[Page 32003-32004]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my03-29]
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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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