[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Proposed Rules]
[Pages 66953-66954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 351

[Docket No. 80N-0280]
RIN 0910-AA01


Vaginal Contraceptive Drug Products for Over-the-Counter Human 
Use; Reopening of the Administrative Record

AGENCY: Food and Drug Administration, HHS.

ACTION: Reopening of the administrative record.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reopening of the administrative record for the proposed rulemaking for 
over-the-counter (OTC) vaginal contraceptive drug products to allow for 
comment on matters considered at the November 22, 1996, joint meeting 
of the Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective 
Drugs, and Antiviral Drugs Advisory Committees. That meeting is part of 
the ongoing review of OTC drug products conducted by FDA.

DATES: Submit comments regarding matters discussed at the November 22, 
1996, advisory committee by March 3, 1997. The administrative record 
will remain open until March 3, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Gloria Chang, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2245.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 12, 1980 
(45 FR 82014), FDA published an advance notice of proposed rulemaking 
to establish a monograph for OTC vaginal contraceptive drug products, 
together with the recommendations of the Advisory Review Panel on OTC 
Contraceptives and Other Vaginal Drug Products (the Panel). The Panel 
recommended that the spermicidal ingredients nonoxynol 9 and octoxynol 
9 be considered generally recognized as safe and effective (45 FR 82014 
at 82028 to 82030 and 82047). The Panel also recommended final 
formulation in vitro testing as an adequate method to determine 
effectiveness (45 FR 82014 at 82047).
    In the Federal Register of February 3, 1995 (60 FR 6892), the 
agency published a proposed rule for OTC vaginal contraceptive drug 
products. This proposal would require manufacturers to obtain approved 
applications for marketing of OTC vaginal contraceptive drug products. 
The agency stated that although nonoxynol 9 and octoxynol 9 kill sperm 
in vitro and in vivo, the spermicidal activity and resulting 
effectiveness of these contraceptive ingredients cannot be considered 
separately from a product's vehicle. Thus, clinical studies are 
necessary to establish the effectiveness of the spermicide's final 
formulation when used in humans. The agency also announced the 
availability of a guidance document that is intended to help 
manufacturers of vaginal contraceptive drug products develop data in 
support of applications (60 FR 6892 at 6893). The administrative record 
for this proposed rule closed on April 3, 1996.
    In response to the proposed rule, 13 professional associations, 1 
health professional, 1 trade association, 10 public health groups, 4 
manufacturers, 1 consumer, and 1 research laboratory submitted 
comments. The majority of the comments objected to the agency's 
proposal to require approved applications for marketing of OTC vaginal 
contraceptive drug products. Copies of the comments received are on 
public display in the Dockets Management Branch (address above).
    On September 24, 1996, FDA met with the Nonprescription Drug

[[Page 66954]]

Manufacturers Association (NDMA) (Ref. 1) to provide industry an 
opportunity to discuss its position on FDA's proposed rule for OTC 
vaginal contraceptive drug products. NDMA opposed the requirement of 
applications for these products and requested that FDA reconsider its 
position to reject monograph standards for OTC vaginal spermicides.
     In the Federal Register of October 30, 1996 (61 FR 55990), FDA 
announced a joint meeting of the Nonprescription Drugs, Reproductive 
Health Drugs, Anti-Infective Drugs, and Antiviral Drugs Advisory 
Committees. The meeting took place on November 20-22, 1996, at the 
Holiday Inn-Gaithersburg, Two Montgomery Village Ave., Gaithersburg, 
MD. On November 22, 1996, the committees discussed proposals and 
guidance for clinical efficacy studies on marketed OTC vaginal 
spermicides. Issues for discussion included the type of data and 
quality of both in vitro and in vivo data needed to support and ensure 
spermicidal efficacy in final formulation.
    Because the issues have a direct impact on FDA's rulemaking on OTC 
vaginal contraceptive drug products, the agency is reopening the 
administrative record to specifically allow for comments on the matters 
discussed at the November 22, 1996, meeting. Transcripts of the 
November 22, 1996, meeting may be requested (by mail or fax) from the 
Freedom of Information Staff (HFI-35), 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857, 301-443-6310; or FAX 301-443-1726. Requests should 
specify date of meeting, name of committee, and a description of 
document(s) requested. The agency requests data and information 
regarding clinical efficacy studies, and in vivo and in vitro data 
needed to support and ensure spermicidal efficacy in final formulation. 
Any individual or group may, on or before March 3, 1997, submit to the 
Dockets Management Branch (address above), comments and data 
specifically limited and relevant to the matters discussed at the 
November 22, 1996, meeting. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. All comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The administrative record will remain open 
until March 3, 1997.

Reference

    (1) Minutes of meeting between FDA and NDMA, September 24, 1996, 
coded MM1, Docket No. 80N-0280, Dockets Management Branch.

    Dated: December 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32273 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F