[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28063]
[[Page Unknown]]
[Federal Register: November 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 333 and 369
[Docket No. 75N-183H]
RIN 0905-AA06
Topical Antimicrobial Drug Products for Over-the-Counter Human
Use; Tentative Final Monograph for Health-Care Antiseptic Drug
Products; Extension of Comment and New Data Periods
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking; extension of comment and new
data periods.
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SUMMARY: The Food and Drug Administration (FDA) is extending to June
19, 1995, the period for comments; to December 15, 1995, the period for
new data; and to February 13, 1996, the period for comments on the new
data for the notice of proposed rulemaking that was published in the
Federal Register of June 17, 1994. That document proposed to establish
conditions under which over-the-counter (OTC) topical health-care
antiseptic drug products are generally recognized as safe and effective
and not misbranded. FDA is taking this action in response to a request
to extend these periods for an additional 6 months to allow interested
persons adequate time to assess and respond to the proposal.
DATES: Written comments by June 19, 1995; new data by December 15,
1995; and comments on the new data by February 13, 1996.
ADDRESSES: Written comments or new data to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm.1-23, 12420 Parklawn
Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug
Evaluation and Research (HFD-810), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5000.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 17, 1994
(59 FR 31402), FDA issued a notice of proposed rulemaking in the form
of an amended tentative final monograph to establish conditions under
which OTC topical health-care antiseptic drug products are generally
recognized as safe and effective and not misbranded. FDA issued this
notice of proposed rulemaking to amend a previous notice of proposed
rulemaking on topical antimicrobial drug products (43 FR 1210, January
6, 1978), after considering the public comments on that notice and
other information in the administrative record for this rulemaking.
Interested persons were given until December 14, 1994, to submit
comments on the proposal; until June 19, 1995, to submit new data; and
until August 17, 1995, to comment on the new data.
In response to the proposal, the Cosmetic, Toiletry, and Fragrance
Association (CTFA), the Soap and Detergent Association (SDA), and the
Nonprescription Drug Manufacturers Association (NDMA) requested a 6-
month extension of the comment and new data periods. (Although not
specifically requested, a 6-month extension of the period for comments
on the new data would result if these requests were to be granted.)
CTFA, SDA, and NDMA noted their representation of the personal care
products industry, manufacturers of products for cleaning and
sanitation and the raw materials used in these products, and
manufacturers of OTC drug products. The associations asserted that the
proposal was broad in scope and raised numerous complex issues,
particularly in the area of the effectiveness testing of these OTC drug
products. The associations stated that more time is needed to assess
fully the significant changes included in the proposal and to respond
adequately to these issues. Observing that the agency's proposal was in
the preparation stage for a considerable number of years, the
associations stated their belief that it is reasonable for the agency
to allow the additional time for comment and new data.
FDA has carefully considered the request and acknowledges the broad
scope of the proposal as well as the complexity of the issues it
raises. The agency believes that additional time for comment and the
submission of new data is in the public interest and will be of
assistance in establishing conditions under which OTC topical health-
care antiseptic drug products are generally recognized as safe and
effective and not misbranded. Thus, the agency finds an extension of
the periods for comments, new data, and comments on the new data to be
appropriate.
Interested persons may, on or before June 19, 1995, submit to the
Dockets Management Branch (address above) written comments on the
proposed regulation. New data may be submitted on or before December
15, 1995, and comments on the new data by February 13, 1996. Three
copies of all data and comments are to be submitted, except that
individuals may submit one copy. All data and comments are to be
identified with the docket number found in brackets in the heading of
this document. Received data and comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 1, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-28063 Filed 11-14-94; 8:45 am]
BILLING CODE 4160-01-F