[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29987]
[[Page Unknown]]
[Federal Register: December 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 358
[Docket No. 81N-0201]
Marketing of Over-the-Counter Pediculicide Drug Products;
Background Documents; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of background documents.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of background documents dealing with its response to two
citizen petitions seeking actions for marketing of over-the-counter
(OTC) pediculicide drug products. This action is being taken to ensure
that all interested persons are aware of the issues that were raised in
the two citizen petitions.
ADDRESSES: Single copies of the background documents may be requested
in writing from the Freedom of Information Staff (HFI-35), Food and
Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD
20857, at a cost of 10 cents per page. Requests should be identified
with the docket number found in brackets in the heading of this
document. The background documents are available for public examination
at the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
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 December 14, 1993
(58 FR 65452), FDA issued a final monograph for OTC pediculicide drug
products (21 CFR part 358, subpart G). The final monograph becomes
effective on December 14, 1994. Prior to that date, jurisdiction over
pediculicide products is vested concurrently with the Environmental
Protection Agency (EPA) and with FDA. EPA and FDA labeling requirements
for these products are different. After December 14, 1994, FDA will
have sole jurisdiction over labeling and other requirements applicable
to OTC pediculicide drug products.
On February 25, 1994, the Nonprescription Drug Manufacturers
Association (NDMA) submitted a citizen petition (Ref. 1) requesting
certain actions because of the dual jurisdiction over OTC pediculicide
drug products that exists until December 14, 1994. On April 14, 1994, a
meeting was held between FDA, EPA, and NDMA (Ref. 2). On April 22,
1994, NDMA submitted a second, more detailed citizen petition (Ref. 3).
NDMA requested FDA to provide industry at least 1 1/2 years from
December 14, 1993 (the date of publication of the final monograph for
OTC pediculicide drug products), for a smooth transition from EPA to
FDA regulations for OTC pediculicide drug products. NDMA also requested
FDA agreement not to bring enforcement proceedings against OTC
pediculicide drug products applied to the human body and bearing EPA-
mandated labeling for 1 year after December 14, 1994. The enforcement
deferral would apply to products distributed with labeling printed
before December 14, 1994, or where the products shipped into interstate
commerce had been in stock before December 14, 1994. NDMA also
submitted a citizen petition to EPA, which responded by notice dated
September 6, 1994 (Ref. 4).
FDA responded to NDMA (Refs. 5 and 6) stating that a 1\1/2\ year
extension to meet FDA labeling requirements would not be granted on a
blanket basis for all products. The agency stated that requests for
extensions would be evaluated on a case-by-case basis. The agency also
indicated that any extension granted will be limited to the quantity of
stock that a company has on hand prior to December 14, 1994. FDA also
stated that, in its discretion, it agrees not to bring enforcement
proceedings against OTC pediculicide drug products conforming with the
final monograph and containing EPA-required labeling for a period of 1
year after the effective date of the final monograph on December 14,
1994.
FDA has placed all of the correspondence on this subject in docket
no. 81N-0201 for OTC pediculicide drug products, to enable interested
persons to see the correspondence. The documents may be seen in the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.,
Monday through Friday.
References
(1) Citizen petition from the Nonprescription Drug Manufacturers
Association to FDA, coded CP1, Docket No. 81N-0201, Dockets
Management Branch.
(2) Memorandum of Meeting, coded MM1, Docket No. 81N-0201,
Dockets Management Branch.
(3) Citizen petition from the Nonprescription Drug Manufacturers
Association to FDA, coded CP2, Docket No. 81N-0201, Dockets
Management Branch.
(4) Pesticide Regulation Notice 94-6, dated September 6, 1994,
Notice to Manufacturers, Producers, Formulators, and Registrants of
Pesticide Products, Office of Pesticides and Toxic Substances,
Environmental Protection Agency, coded REF1, Docket No. 81N-0201,
Dockets Management Branch.
(5) Letter from W. E. Gilbertson, FDA, to R. W. Soller,
Nonprescription Drug Manufacturers Association, coded LET18, Docket
No. 81N-0201, Dockets Management Branch.
(6) Letter from R. G. Chesemore, FDA, to R. W. Soller,
Nonprescription Drug Manufacturers Association, coded PAV1, Docket
No. 81N-0201, Dockets Management Branch.
Dated: November 30, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29987 Filed 12-5-94; 8:45 am]
BILLING CODE 4160-01-F